Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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 gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.

Detailed Description
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OBJECTIVES: Primary Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel. Secondary Determine the toxicity of this regimen in these patients. Determine the overall survival of patients treated with this regimen. Determine the time to treatment failure and progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with a platinum-containing regimen (platinum-resistant disease vs platinum-sensitive disease). Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 3 additional courses beyond CR (≥ 6 total courses of treatment). PROJECTED ACCRUAL: Approximately 36-62 patients (19-29 for stratum I [platinum-resistant disease] and 17-33 for stratum II [platinum-sensitive disease]) will be accrued for this study.

Official Title
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Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer

Conditions
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Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial or peritoneal cavity cancer Relapsed or refractory disease after prior first-line therapy with a platinum-containing regimen Platinum-sensitive or -resistant disease Platinum resistance is defined as relapsed or progressive disease within 6 months after completion of a platinum-containing regimen Measurable or evaluable disease Evaluable disease is defined as CA 125 > 70 U/mL that has doubled from a baseline determination confirmed by ≥ 2 separate blood samples taken > 4 weeks apart OR other evidence demonstrating progressive disease after initial treatment regimen PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin normal Meets 1 of the following criteria: AST or ALT normal AND alkaline phosphatase (AP) ≤ 5 times upper limit of normal (ULN) AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN AST or ALT ≤ 5 times ULN AND AP normal Renal Creatinine clearance > 30 mL/min Creatinine < 2.5 mg/dL Cardiovascular No congestive heart failure No second or third degree heart block No myocardial infarction within the past 3 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No peripheral neuropathy > grade 1 No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Prior paclitaxel allowed No more than 1 prior chemotherapy regimen First-line platinum-based chemotherapy followed by consolidation therapy in the setting of a clinical and serologic complete response is considered 1 regimen No prior gemcitabine or docetaxel Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy and recovered Surgery Not specified Other More than 28 days since prior and no other concurrent investigational drugs for this cancer No other concurrent treatment or alternative therapy for this cancer

Ages Eligible for Study
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Minimum Age: 18 Years
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel & Gemcitabine hydrochloride<br>Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle | Drug: Docetaxel<br>* 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days<br>* Other names: Taxotere®;Drug: Gemcitabine hydrochloride<br>* 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days<br>* Other names: Gemzar ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate to the Combination of Gemcitabine and Docetaxel in Patients With Platinum Sensitive and Resistant Epithelial Ovarian or Peritoneal Cancer. |  | Disease status by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or Gynecological Cancer Intergroup (GCIG) CA-125 criteria was assessed every two cycles from enrollment up to progression, death, or five years (whichever occurred first). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | Progression-free survival estimated using Kaplan-Meier's product-limit method. | Every two cycles until disease progression or death, assessed up to 5 years | 

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