Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

22. července 2019 aktualizováno: National Cancer Institute (NCI)

A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

This randomized phase II trial studies how well paclitaxel when given together with or without pazopanib hydrochloride works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used in chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel is more effective when given with or without pazopanib hydrochloride in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel and pazopanib (pazopanib hydrochloride) compared to weekly paclitaxel and placebo in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

II. To estimate and compare the proportion of patients responding to therapy by Response Evaluation Criteria in Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm.

TERTIARY OBJECTIVES:

I. To explore the association between plasma cytokines and angiogenic markers and progression-free and overall survival.

II. To explore the association between single-nucleotide polymorphisms (SNPs) and progression-free and overall survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 and placebo orally (PO) daily on days 1-28.

ARM II: Patients receive paclitaxel as in Arm I and pazopanib hydrochloride PO daily on days 1-28.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Typ studie

Intervenční

Zápis (Aktuální)

106

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Mobile, Alabama, Spojené státy, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85012
        • Gynecologic Oncology Group of Arizona
    • California
      • Burbank, California, Spojené státy, 91505
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Newport Beach, California, Spojené státy, 92663
        • Gynecologic Oncology Associates-Newport Beach
    • Connecticut
      • Farmington, Connecticut, Spojené státy, 06030
        • University of Connecticut
      • Hartford, Connecticut, Spojené státy, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, Spojené státy, 06102
        • Hartford Hospital
      • New Britain, Connecticut, Spojené státy, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, Spojené státy, 19958
        • Beebe Medical Center
      • Newark, Delaware, Spojené státy, 19718
        • Christiana Care Health System-Christiana Hospital
    • Florida
      • Orlando, Florida, Spojené státy, 32803
        • Florida Hospital Orlando
      • Saint Petersburg, Florida, Spojené státy, 33701
        • Women's Cancer Associates
    • Georgia
      • Gainesville, Georgia, Spojené státy, 30501
        • Northeast Georgia Medical Center-Gainesville
      • Macon, Georgia, Spojené státy, 31201
        • Central Georgia Gynecologic Oncology
      • Savannah, Georgia, Spojené státy, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Spojené státy, 96813
        • University of Hawaii Cancer Center
    • Idaho
      • Boise, Idaho, Spojené státy, 83706
        • Saint Alphonsus Cancer Care Center-Boise
    • Illinois
      • Chicago, Illinois, Spojené státy, 60611
        • Northwestern University
      • Chicago, Illinois, Spojené státy, 60612
        • Rush University Medical Center
      • Hinsdale, Illinois, Spojené státy, 60521
        • Sudarshan K Sharma MD Limted-Gynecologic Oncology
    • Indiana
      • Indianapolis, Indiana, Spojené státy, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Spojené státy, 46260
        • Saint Vincent Hospital and Health Care Center
    • Iowa
      • Ames, Iowa, Spojené státy, 50010
        • McFarland Clinic PC - Ames
      • Des Moines, Iowa, Spojené státy, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Spojené státy, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Spojené státy, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, Spojené státy, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Spojené státy, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, Spojené státy, 50314
        • Medical Oncology and Hematology Associates-Laurel
    • Kansas
      • Chanute, Kansas, Spojené státy, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Spojené státy, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Spojené státy, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Spojené státy, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Spojené státy, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Spojené státy, 67068
        • Cancer Center of Kansas-Kingman
      • Liberal, Kansas, Spojené státy, 67905
        • Cancer Center of Kansas-Liberal
      • Newton, Kansas, Spojené státy, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, Spojené státy, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, Spojené státy, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Spojené státy, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Spojené státy, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Spojené státy, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Spojené státy, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Spojené státy, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Spojené státy, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, Spojené státy, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, Spojené státy, 67156
        • Cancer Center of Kansas - Winfield
    • Maine
      • Portland, Maine, Spojené státy, 04102
        • Maine Medical Center-Bramhall Campus
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Spojené státy, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, Spojené státy, 21204
        • Greater Baltimore Medical Center
      • Elkton, Maryland, Spojené státy, 21921
        • Union Hospital of Cecil County
    • Massachusetts
      • Burlington, Massachusetts, Spojené státy, 01805
        • Lahey Hospital and Medical Center
      • Springfield, Massachusetts, Spojené státy, 01199
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48106
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, Spojené státy, 48106
        • Michigan Cancer Research Consortium NCORP
      • Battle Creek, Michigan, Spojené státy, 49017
        • Bronson Battle Creek
      • Big Rapids, Michigan, Spojené státy, 49307
        • Spectrum Health Big Rapids Hospital
      • Dearborn, Michigan, Spojené státy, 48124
        • Beaumont Hospital-Dearborn
      • Detroit, Michigan, Spojené státy, 48236
        • Saint John Hospital and Medical Center
      • Flint, Michigan, Spojené státy, 48503
        • Hurley Medical Center
      • Grand Blanc, Michigan, Spojené státy, 48439
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, Spojené státy, 49503
        • Spectrum Health at Butterworth Campus
      • Grand Rapids, Michigan, Spojené státy, 49503
        • Mercy Health Saint Mary's
      • Grand Rapids, Michigan, Spojené státy, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Jackson, Michigan, Spojené státy, 49201
        • Allegiance Health
      • Lansing, Michigan, Spojené státy, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Spojené státy, 48154
        • Saint Mary Mercy Hospital
      • Muskegon, Michigan, Spojené státy, 49444
        • Mercy Health Mercy Campus
      • Pontiac, Michigan, Spojené státy, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Spojené státy, 48060
        • Lake Huron Medical Center
      • Saginaw, Michigan, Spojené státy, 48601
        • Saint Mary's of Michigan
      • Traverse City, Michigan, Spojené státy, 49684
        • Munson Medical Center
      • Warren, Michigan, Spojené státy, 48093
        • Saint John Macomb-Oakland Hospital
    • Mississippi
      • Jackson, Mississippi, Spojené státy, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Joplin, Missouri, Spojené státy, 64804
        • Freeman Health System
      • Saint Louis, Missouri, Spojené státy, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, Spojené státy, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, Spojené státy, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Spojené státy, 65804
        • Mercy Hospital Springfield
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89169
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Spojené státy, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Spojené státy, 08103
        • Cooper Hospital University Medical Center
    • New York
      • Albany, New York, Spojené státy, 12208
        • Women's Cancer Care Associates LLC
      • Stony Brook, New York, Spojené státy, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Spojené státy, 28204
        • Novant Health Presbyterian Medical Center
    • Ohio
      • Akron, Ohio, Spojené státy, 44304
        • Summa Akron City Hospital/Cooper Cancer Center
      • Cincinnati, Ohio, Spojené státy, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Cleveland, Ohio, Spojené státy, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Spojené státy, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Spojené státy, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Spojené státy, 43214
        • Riverside Methodist Hospital
      • Kettering, Ohio, Spojené státy, 45429
        • Kettering Medical Center
      • Mayfield Heights, Ohio, Spojené státy, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Spojené státy, 44060
        • Lake University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Spojené státy, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, Spojené státy, 19001
        • Abington Memorial Hospital
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • West Reading, Pennsylvania, Spojené státy, 19611
        • Reading Hospital
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02905
        • Women and Infants Hospital
    • South Carolina
      • Greenville, South Carolina, Spojené státy, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, Spojené státy, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Seneca, South Carolina, Spojené státy, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, Spojené státy, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • Texas
      • Dallas, Texas, Spojené státy, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Fort Worth, Texas, Spojené státy, 76104
        • Baylor All Saints Medical Center at Fort Worth
    • Washington
      • Bellingham, Washington, Spojené státy, 98226
        • PeaceHealth Medical Group PC
      • Bremerton, Washington, Spojené státy, 98310
        • Harrison HealthPartners Hematology and Oncology-Bremerton
      • Bremerton, Washington, Spojené státy, 98310
        • Harrison Medical Center
      • Everett, Washington, Spojené státy, 98201
        • Providence Regional Cancer Partnership
      • Mount Vernon, Washington, Spojené státy, 98273
        • Skagit Valley Hospital Regional Cancer Care Center
      • Poulsbo, Washington, Spojené státy, 98370
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, Spojené státy, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Spojené státy, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Spojené státy, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Spojené státy, 98112
        • Kaiser Permanente Washington
      • Seattle, Washington, Spojené státy, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Spojené státy, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Spojené státy, 98133
        • Northwest Hospital
      • Sequim, Washington, Spojené státy, 98384
        • Olympic Medical Cancer Care Center
      • Spokane, Washington, Spojené státy, 99204
        • Rockwood Cancer Treatment Center-DHEC-Downtown
      • Spokane, Washington, Spojené státy, 99202
        • Cancer Care Northwest - Spokane South
      • Tacoma, Washington, Spojené státy, 98405
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, Spojené státy, 98405
        • Saint Joseph Medical Center
      • Walla Walla, Washington, Spojené státy, 99362
        • Providence Saint Mary Regional Cancer Center
      • Wenatchee, Washington, Spojené státy, 98801
        • Wenatchee Valley Hospital and Clinics
    • Wisconsin
      • Eau Claire, Wisconsin, Spojené státy, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Spojené státy, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Spojené státy, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, Spojené státy, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Manitowoc, Wisconsin, Spojené státy, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Spojené státy, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Spojené státy, 54449
        • Marshfield Clinic
      • Minocqua, Wisconsin, Spojené státy, 54548
        • Marshfield Clinic-Minocqua Center
      • Rhinelander, Wisconsin, Spojené státy, 54501
        • Ascension Saint Mary's Hospital
      • Rice Lake, Wisconsin, Spojené státy, 54868
        • Marshfield Clinic-Rice Lake Center
      • Stevens Point, Wisconsin, Spojené státy, 54481
        • Ascension Saint Michael's Hospital
      • Weston, Wisconsin, Spojené státy, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Spojené státy, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

Inclusion Criteria:

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report

  • Patients must have measurable disease or non-measurable (detectable) disease

    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI

    • Non-measurable (detectable) disease in a patient is defined in this protocol as one who does not have measurable disease but has at least one of the following conditions:

      • Ascites and/or pleural effusion attributed to tumor
      • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
  • Patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecology Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III or Rare Tumor protocol for the same patient population; in addition, patients must not be eligible for the currently active phase II cytotoxic protocol in platinum resistant disease
  • Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
  • Patients who have received two or three prior regimens must have a GOG performance status of 0 or 1
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted (non-cytotoxic) agents, and immunologic agents, must be discontinued at least three weeks prior to registration; chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor (VEGF) receptor fusion proteins (including VEGF TRAP/aflibercept) must be discontinued for at least 12 weeks prior to registration
  • At least 4 weeks must have elapsed since the patient underwent any major surgery (e.g., major: laparotomy, laparoscopy, thoracotomy, video-assisted thorascopic surgery [VATS]); there is no restriction on minor procedures (e.g., minor: central venous access catheter placement, ureteral stent placement or exchange, paracentesis, thoracentesis)
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab), or extended therapy administered after surgical or non-surgical assessment; if patients were treated with paclitaxel for their primary disease, this can have been given weekly or every 3 weeks
  • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
  • Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen
  • Patients must have NOT received any biologic/targeted (non-cytotoxic) therapy targeting the VEGF and/or platelet-derived growth factor (PDGF) pathways for management of recurrent or persistent disease
  • For the purposes of this study, poly (ADP-ribose) polymerase (PARP) inhibitors will be considered "cytotoxic"; patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regimen when given alone
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL
  • Platelets greater than or equal to 100,000/mcL
  • Hemoglobin greater than or equal to 9 g/dL
  • Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x upper limit of normal (ULN) (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin)
  • Partial thromboplastin time (PTT) less than or equal to 1.5 x ULN
  • Creatinine less than or equal to 1.5 x institutional ULN
  • Urine protein should be screened by urinalysis; if urine protein is 2+ or higher, 24-hour urine protein should be obtained and the level must be < 1000 mg (< 1.0 g/24 hours [hrs]) for patient enrollment
  • Bilirubin less than or equal to 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN
  • Subjects who have BOTH bilirubin greater than ULN and AST/ALT greater than ULN are not eligible
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Patients must have normal baseline thyroid function tests (thyroid-stimulating hormone [TSH], T3, T4); a history of hypothyroidism and/or hyperthyroidism is allowed, as long as the patient has stable well-controlled thyroid function for a minimum of 2 months
  • Neuropathy (sensory and motor) less than or equal to grade 1
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information

  • Patients must be capable of taking and absorbing oral medications; a patient must be clear of the following:

    • Any lesion, whether induced by tumor, radiation, or other conditions, which makes it difficult to swallow tablets
    • Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome
  • Any concomitant medications that are associated with a risk of corrected QT (QTc) prolongation and/or Torsades de Pointes should be discontinued or replaced with drugs that do not carry these risks, if possible; patients who must take medication with a risk of possible risk of Torsades de Pointes should be watched carefully for symptoms of QTc prolongation, such as syncope
  • Patients with personal or family history of congenital long QTc syndrome are NOT eligible
  • Strong inhibitors of cytochrome P-450 system (CYP)3A4 are prohibited
  • Strong inducers of CYP3A4 are prohibited
  • Concomitant use of agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended

Exclusion Criteria:

  • Patients who have had previous treatment with pazopanib; patients who have had previous treatment with weekly paclitaxel for recurrent or persistent disease
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease

  • Patients with clinically significant cardiovascular disease; this includes:

    • Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications
    • Congenital long QT syndrome or baseline QTc greater than 480 milliseconds
    • Myocardial infarction or unstable angina within 6 months prior to registration
    • New York Heart Association (NYHA) class II or greater congestive heart failure

    • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication

      • This does not include asymptomatic atrial fibrillation with controlled ventricular rate
    • Patients who have received prior treatment with an anthracycline (including doxorubicin and/or liposomal doxorubicin) must have an echocardiogram assessment and are excluded if they have an ejection fraction less than 50%
    • CTCAE grade 2 or greater peripheral vascular disease (at least brief [less than 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
    • History of cardiac angioplasty or stenting within 6 months prior to registration
    • History of coronary artery bypass graft surgery within 6 months prior to registration
    • Arterial thrombosis within 6 months prior to registration
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to the first date of study treatment
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pazopanib
  • Known human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy

  • Patients with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known gastrointestinal intraluminal metastatic lesions (gastrointestinal serosa metastatic lesions are permitted)
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease)
    • Patients with clinical symptoms or signs of gastrointestinal obstruction
    • Patients who require parenteral hydration and/or nutrition
  • Patients who are pregnant or nursing
  • History of hemoptysis in excess of 2.5 mL (½ teaspoon) within 8 weeks prior to first dose of pazopanib
  • Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Arm I (paclitaxel and placebo)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Jiný: Laboratorní analýza biomarkerů
Korelační studie
Jiný: Placebo
Vzhledem k PO
Ostatní jména:
  • placebo terapie
  • PLCB
  • předstíraná terapie
Lék: Paklitaxel
Vzhledem k tomu, IV
Ostatní jména:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Experimentální: Arm II (paclitaxel and pazopanib hydrochloride)
Patients receive paclitaxel as in arm I and pazopanib hydrochloride PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Jiný: Laboratorní analýza biomarkerů
Korelační studie
Lék: Pazopanib hydrochlorid
Vzhledem k PO
Ostatní jména:
  • GW786034B
  • Votrient
Lék: Paklitaxel
Vzhledem k tomu, IV
Ostatní jména:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression Free Survival
Časové okno: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years
The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adverse Events as Assessed by CTCAE v.4
Časové okno: From baseline to 30 days after last dose of drug.
All grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
From baseline to 30 days after last dose of drug.
Proportion of Participants With Tumor Response by RECIST
Časové okno: Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years
Patients with Complete and Partial Tumor Response by RECIST 1.1. Responses (CR and PR) require confirmation at greater than or equal to 4 weeks from initial documentation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years
Percentage of Participants With Tumor Response by CA-125
Časové okno: Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.
Response as evaluated by CA-125 levels. Response is indicated if CA-125 reduced by 50% of the baseline measure.
Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.
Overall Survival (OS)
Časové okno: Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years
Overall survival
Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform
Časové okno: Up to 5 years
Analyzed using deoxyribonucleic acid isolated from whole blood specimens.
Up to 5 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Spolupracovníci

NRG Oncology

Vyšetřovatelé

  • Vrchní vyšetřovatel: Debra Richardson, NRG Oncology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. prosince 2011

Primární dokončení (Aktuální)

27. ledna 2018

Dokončení studie (Aktuální)

27. ledna 2018

Termíny zápisu do studia

První předloženo

8. listopadu 2011

První předloženo, které splnilo kritéria kontroly kvality

8. listopadu 2011

První zveřejněno (Odhad)

10. listopadu 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. července 2019

Naposledy ověřeno

1. července 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCI-2011-03635 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (Grant/smlouva NIH USA)
  • U10CA027469 (Grant/smlouva NIH USA)
  • CDR0000716028
  • GOG-0186J (Jiný identifikátor: CTEP)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Laboratorní analýza biomarkerů

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Montenegro

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit