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

22 luglio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

106

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Altro: Placebo
Dato PO
Altri nomi:
  • terapia placebo
  • PLCB
  • finta terapia
Droga: Paclitaxel
Dato IV
Altri nomi:
  • Tassolo
  • Anzatax
  • Asotax
  • Bristaxolo
  • Praxel
  • Taxol Konzentrat
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Droga: Pazopanib cloridrato
Dato PO
Altri nomi:
  • GW786034B
  • Votriente
Droga: Paclitaxel
Dato IV
Altri nomi:
  • Tassolo
  • Anzatax
  • Asotax
  • Bristaxolo
  • Praxel
  • Taxol Konzentrat

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse Events as Assessed by CTCAE v.4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform
Lasso di tempo: Up to 5 years
Analyzed using deoxyribonucleic acid isolated from whole blood specimens.
Up to 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Collaboratori

NRG Oncology

Investigatori

  • Investigatore principale: Debra Richardson, NRG Oncology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 dicembre 2011

Completamento primario (Effettivo)

27 gennaio 2018

Completamento dello studio (Effettivo)

27 gennaio 2018

Date di iscrizione allo studio

Primo inviato

8 novembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2011

Primo Inserito (Stima)

10 novembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2011-03635 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U10CA027469 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000716028
  • GOG-0186J (Altro identificatore: CTEP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

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