Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

Detailed Description
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OBJECTIVES: Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse. Determine the response rates (complete and partial response) in patients treated with this regimen. Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses. After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

Official Title
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A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma

Conditions
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Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Biological: pegfilgrastim
* Drug: carboplatin
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer Stage III or IV disease No borderline tumors Measurable or evaluable disease Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart) In first relapse Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hepatic Bilirubin normal Meets 1 of the following criteria: SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal Renal Creatinine ≤ 2.0 mg/dL Creatinine clearance > 50 mL/min Cardiovascular LVEF ≥ 50% No poorly controlled arrhythmia No unstable coronary artery disease or myocardial infarction within the past year Other HIV negative No pre-existing peripheral neuropathy > grade 2 No history of allergy to study drugs PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy and recovered Surgery Recovered from recent prior surgery Other No concurrent myelosuppressive therapy

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pegfilgrastim|nan|
|Drug: carboplatin|nan|
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Response rates (complete and partial response) |  |  | 
| Relapse rates |  |  | 
| Event-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity cancer