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Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer - NCT00108745-54601(Clinical Trial 124632)



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City:  La Crosse
State:  
WI
Zip Code: 54601
Conditions: Fallopian Tube Cancer - Ovarian Cancer - Peritoneal Cavity Cancer
Purpose: RATIONALE: Drugs used in chemotherapy, such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer. PURPOSE: This randomized phase III trial is studying paclitaxel to see how well it works compared to polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV ovarian epithelial or peritoneal cancer or fallopian tube cancer.
Study summary: OBJECTIVES: Primary - Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer in clinical complete response after prior primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until documented disease progression. Secondary - Compare progression-free survival of patients treated with these drugs. - Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in these patients. - Compare the quality of life of patients treated with these drugs. Tertiary - Correlate angiogenic marker expression with overall or progression-free survival of patients treated with these drugs. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1. - Arm II: Patients receive paclitaxel IV over 3 hours on day 1. - Arm III: Patients receive no further anticancer treatment until evidence of disease progression. In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at completion of study treatment, and then at 1 year after completion of study treatment. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for this study within 8.5 years.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer - The following histologic epithelial cell types are allowed: - Serous adenocarcinoma - Endometrioid adenocarcinoma - Mucinous adenocarcinoma - Undifferentiated carcinoma - Clear cell adenocarcinoma - Mixed epithelial carcinoma - Transitional cell carcinoma - Malignant Brenner tumor - Adenocarcinoma not otherwise specified - The following histologic cell types are not allowed: - Germ cell tumor - Sex cord-stromal tumor - Carcinosarcoma - Mixed müllerian tumor or carcinosarcoma - Metastatic carcinoma from other sites to the ovary - Low malignant potential (LMP) tumor (borderline carcinoma), including micropapillary serous carcinoma - Patients with a prior diagnosis of LMP tumor that was surgically resected and who subsequently developed invasive adenocarcinoma are eligible provided patient did not receive prior chemotherapy for the ovarian LMP tumor - Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND have tissue available for histologic evaluation - Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial surgery - Must have completed at least 5, but no more that 8 courses of primary therapy comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based combination chemotherapy within the past 12 weeks AND have no symptoms of persistent cancer after completion of therapy - CT scan of the abdomen and/or pelvis normal - CA 125 normal - Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided the following criteria is met: - Must have undergone interval abdominal surgery after at least one but no more than 6 courses of standard chemotherapy - Surgery must meet the same criteria as the up front surgery, including tissue diagnosis for confirmation of primary tumor site and stage III or IV disease - Patients must have received at least 2 courses after interval abdominal surgery - No synchronous primary endometrial cancer or history of primary endometrial cancer, unless all of the following criteria are met: - Stage ≤ IB - Less than 3 mm invasion without vascular or lymphatic invasion - No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion PATIENT CHARACTERISTICS: Age - Not specified Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - No active bleeding Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN - PT or PTT normal - No acute or chronic hepatitis Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed provided the disease has remained stable within the past 6 months - No unstable angina - No myocardial infarction within the past 6 months Other - No neuropathy (sensory and motor) ≥ grade 2 - No active infection requiring antibiotics - No ongoing gastrointestinal bleeding requiring blood product support - No circumstance that would preclude study participation - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - Not pregnant or nursing - Fertile patients must agree to use an effective contraception method - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or pelvic tumor Chemotherapy - See Disease Characteristics - No prior polyglutamate paclitaxel - No prior chemotherapy for any other abdominal or pelvic tumor - More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND no recurrent or metastatic disease Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to any portion of the abdominal cavity or pelvis - More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND no recurrent or metastatic disease Surgery - See Disease Characteristics Other - No prior investigational therapy for any other abdominal or pelvic tumor - No prior anticancer therapy that would preclude study therapy - No concurrent amifostine or other protective agents
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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