- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00662129
Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES:
Primary
- To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.
Secondary
- To determine the overall survival of patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the confirmed response rate in patients treated with this regimen.
- To determine the duration of response in patients treated with this regimen.
- To determine the time to treatment failure in patients treated with this regimen.
- To determine the quality of life of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and after every other course, and then after completion of treatment.
After completion of study treatment, patients are followed periodically for 5 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259-5499
- Mayo Clinic Scottsdale
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic - Jacksonville
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Indiana
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Beech Grove, Indiana, Stati Uniti, 46107
- St. Francis Hospital and Health Centers - Beech Grove Campus
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Richmond, Indiana, Stati Uniti, 47374
- Reid Hospital & Health Care Services
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Iowa
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Clive, Iowa, Stati Uniti, 50325
- Medical Oncology and Hematology Associates - West Des Moines
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Des Moines, Iowa, Stati Uniti, 50309
- CCOP - Iowa Oncology Research Association
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Des Moines, Iowa, Stati Uniti, 50309
- John Stoddard Cancer Center at Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Medical Oncology and Hematology Associates at Mercy Cancer Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Cancer Center at Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50316
- John Stoddard Cancer Center at Iowa Lutheran Hospital
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Mason City, Iowa, Stati Uniti, 50401
- Mercy Cancer Center at Mercy Medical Center - North Iowa
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Ottumwa, Iowa, Stati Uniti, 52501
- McCreery Cancer Center at Ottumwa Regional
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stati Uniti, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Stati Uniti, 51104
- Mercy Medical Center - Sioux City
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
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Battle Creek, Michigan, Stati Uniti, 49017
- Battle Creek Health System Cancer Care Center
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Big Rapids, Michigan, Stati Uniti, 49307
- Mecosta County Medical Center
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Dearborn, Michigan, Stati Uniti, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, Stati Uniti, 49503
- Butterworth Hospital at Spectrum Health
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Grand Rapids, Michigan, Stati Uniti, 49503
- CCOP - Grand Rapids
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Grand Rapids, Michigan, Stati Uniti, 49503
- Lacks Cancer Center at Saint Mary's Health Care
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Stati Uniti, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Stati Uniti, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Stati Uniti, 48154
- St. Mary Mercy Hospital
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Muskegon, Michigan, Stati Uniti, 49443
- Mercy General Health Partners
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Pontiac, Michigan, Stati Uniti, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Stati Uniti, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stati Uniti, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Traverse City, Michigan, Stati Uniti, 49684
- Munson Medical Center
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Warren, Michigan, Stati Uniti, 48093
- St. John Macomb Hospital
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Wyoming, Michigan, Stati Uniti, 49519
- Metro Health Hospital
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Minnesota
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Alexandria, Minnesota, Stati Uniti, 56308
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy and Unity Cancer Center at Mercy Hospital
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stati Uniti, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Stati Uniti, 55805
- Miller - Dwan Medical Center
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Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Stati Uniti, 55432
- Mercy and Unity Cancer Center at Unity Hospital
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Hutchinson, Minnesota, Stati Uniti, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology, PA - Maplewood
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Maplewood, Minnesota, Stati Uniti, 55109
- HealthEast Cancer Care at St. John's Hospital
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Minneapolis, Minnesota, Stati Uniti, 55407
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center - Minneapolis
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Robbinsdale, Minnesota, Stati Uniti, 55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stati Uniti, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- CCOP - Metro-Minnesota
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Cancer Center
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Shakopee, Minnesota, Stati Uniti, 55379
- St. Francis Cancer Center at St. Francis Medical Center
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St. Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital Cancer Care Center
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stati Uniti, 56201
- Willmar Cancer Center at Rice Memorial Hospital
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Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology, PA - Woodbury
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Montana
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Great Falls, Montana, Stati Uniti, 59405-5309
- Big Sky Oncology
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Great Falls, Montana, Stati Uniti, 59405
- Sletten Cancer Institute at Benefis Healthcare
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, Stati Uniti, 68122
- Immanuel Medical Center
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Omaha, Nebraska, Stati Uniti, 68124
- Alegant Health Cancer Center at Bergan Mercy Medical Center
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Omaha, Nebraska, Stati Uniti, 68131-2197
- Creighton University Medical Center
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North Dakota
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Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stati Uniti, 58502
- St. Alexius Medical Center Cancer Center
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Ohio
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Dayton, Ohio, Stati Uniti, 45405
- Grandview Hospital
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Dayton, Ohio, Stati Uniti, 45406
- Good Samaritan Hospital
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Dayton, Ohio, Stati Uniti, 45409
- David L. Rike Cancer Center at Miami Valley Hospital
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Dayton, Ohio, Stati Uniti, 45415
- Samaritan North Cancer Care Center
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Dayton, Ohio, Stati Uniti, 45420
- CCOP - Dayton
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Findlay, Ohio, Stati Uniti, 45840
- Blanchard Valley Medical Associates
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Franklin, Ohio, Stati Uniti, 45005-1066
- Middletown Regional Hospital
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Greenville, Ohio, Stati Uniti, 45331
- Wayne Hospital
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Kettering, Ohio, Stati Uniti, 45429
- Charles F. Kettering Memorial Hospital
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Troy, Ohio, Stati Uniti, 45373-1300
- UVMC Cancer Care Center at Upper Valley Medical Center
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Wilmington, Ohio, Stati Uniti, 45177
- Clinton Memorial Hospital
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Xenia, Ohio, Stati Uniti, 45385
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
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Oklahoma
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Tulsa, Oklahoma, Stati Uniti, 74136
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
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Pennsylvania
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Allentown, Pennsylvania, Stati Uniti, 18105
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Stati Uniti, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed infiltrating breast cancer
- Clinical evidence of metastatic disease
Measurable disease, defined as at least one measurable lesion per RECIST criteria
No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab
No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan
CNS metastasis controlled by prior surgery and/or radiotherapy allowed
- Must be asymptomatic for ≥ 2 months with no evidence of progression prior to study entry
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 mg/dL
Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein
- Patients discovered to have ≥ 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study therapy
- Able to complete questionnaires alone or with assistance
- No peripheral neuropathy > grade 1
- No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents
- No stage III or IV invasive, non-breast malignancy within the past 5 years
No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix
- Patient must not be receiving other specific treatment for a prior malignancy
No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2 occasions at least 5 minutes apart)
- Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days
- No bleeding diathesis or uncontrolled coagulopathy
- No hemoptysis within the past 6 months
- No prior arterial or venous thrombosis within the past 12 months
- No history of cerebrovascular accident
- No history of hypertensive crisis or hypertensive encephalopathy
- No abdominal fistula or gastrointestinal perforation within the past 6 months
- No serious non-healing wound, ulcer, or fracture
No clinically significant cardiac disease, defined as any of the following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Unstable angina
- Cardiac arrhythmias not well controlled with medication
- Myocardial infarction within the past 12 months
- No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior chemotherapy for metastatic disease
- May have received one prior adjuvant chemotherapy regimen
Prior neoadjuvant chemotherapy allowed
- More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy
- Prior hormonal therapy in either adjuvant or metastatic setting allowed
More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)
- Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed
- More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug
- More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)
- More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
More than 1 week since prior minor surgery (e.g., core biopsy)
- Placement of a vascular access device within 7 days is allowed
- More than 3 months since prior neurosurgery
No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
- Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: paclitaxel + gemcitabine + bevacizumab
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after every other course, and then after completion of treatment. After completion of study treatment, patients are followed periodically for 5 years. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
6-month Progression-free Survival (PFS) Rate
Lasso di tempo: at 6 months
|
The primary endpoint of this trial is the 6-month progression-free survival rate.
A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success).
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution.
Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
|
at 6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Survival Time
Lasso di tempo: Up to 5 years
|
Overall Survival time is defined as the time from registration to death due to any cause.
The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).
|
Up to 5 years
|
PFS Time
Lasso di tempo: Up to 5 years
|
Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression.
If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death.
The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958).
Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
|
Up to 5 years
|
Confirmed Response (Complete or Partial Response) Rate
Lasso di tempo: Up to 5 years
|
A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart.
The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100.
The appropriate confidence interval will be calculated based on the binomial distribution.
|
Up to 5 years
|
Duration of Response
Lasso di tempo: Up to 5 years
|
Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death.
In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation.
The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).
|
Up to 5 years
|
Time to Treatment Failure
Lasso di tempo: Up to 5 years
|
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment.
The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958).
Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.
|
Up to 5 years
|
Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8
Lasso di tempo: From baseline to end of Cycle 8; Up to 24 weeks
|
Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0. (*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986. |
From baseline to end of Cycle 8; Up to 24 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Cattedra di studio: Donald W. Northfelt, MD, FACP, Mayo Clinic
Pubblicazioni e link utili
Pubblicazioni generali
- Northfelt DW, Dueck AC, Flynn TP, et al.: Phase II trial combining nab-paclitaxel (NP), gemcitabine (G), and bevacizumab (B) in patients (pts) with metastatic breast cancer (MBC): NCCTG N0735. [Abstract] J Clin Oncol 29 (Suppl 15): A-1126, 2011.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Gemcitabina
- Paclitaxel
- Bevacizumab
- Paclitaxel legato all'albumina
Altri numeri di identificazione dello studio
- NCCTG-N0735
- NCI-2009-00666 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
- CDR0000593581 (Identificatore di registro: PDQ (Physician Data Query))
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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