Carboplatin Plus Paclitaxel With or Without Continued Low-Dose Paclitaxel in Treating Patients With Early-Stage Ovarian Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin and paclitaxel alone for early-stage ovarian cancer. PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel alone too see how well they work compared to carboplatin and paclitaxel together with continued low-dose paclitaxel in treating patients with early-stage ovarian cancer.

Detailed Description
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OBJECTIVES: Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel. Assess the frequency and severity of toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Four weeks after the completion of paclitaxel and carboplatin, patients receive low-dose paclitaxel IV over 1 hour once a week for 24 weeks. Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes. Treatment repeats every 21 days for 3 courses. Patients then undergo observation. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5.5 years.

Official Title
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A Randomized Phase III Trial of IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Low Dose Paclitaxel 40 mg/m2/wk Versus IV Carboplatin (AUC 6) and Paclitaxel 175 mg/m2 Q 21 Days x 3 Courses Plus Observation in Patients With Early Stage Ovarian Carcinoma

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer of one of the following histologic cell types: Serous adenocarcinoma Malignant Brenner's tumor Mucinous adenocarcinoma Endometrioid Adenocarcinoma Clear cell adenocarcinoma Undifferentiated carcinoma Transitional cell Mixed epithelial carcinoma Adenocarcinoma - not otherwise specified Meets 1 of the following criteria: Stage Ia or Ib, grade 3 or clear cell Stage Ic or II, all grades/histologies Complete surgical staging No tumors of low malignant potential (borderline tumors) PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No other invasive malignancies within the past 5 years except nonmelanoma skin cancer No major systemic medical illness expected to affect survival Body surface area no greater than 2.0 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No prior treatment for this malignancy except surgical staging No prior anticancer therapy that would preclude study participation

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboplatin, paclitaxel, low dose paclitaxel<br>carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later | Drug: carboplatin<br> <br> Drug: paclitaxel<br> <br> |
| Active Comparator: Carboplatin, paclitaxel<br>carboplatin, paclitaxel | Drug: carboplatin<br> <br> Drug: paclitaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | The percent of participants with disease recurrence within 5 years | Up to 5 years | 
| Overall Survival | Number of deaths during study and follow up. | up to 96 months | 
| Number of Participants With Adverse Events Grade 3 or Greater | Toxicities, Grade 3 or greater (CTC version 2.0) by treatment arm for all treated participants | Throughout study treatment lasting up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brenner tumor, stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian mixed epithelial carcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma