Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

Study Overview
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Brief Summary
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This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.

Detailed Description
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The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol*) weekly administered, in lower doses in combination with topotecan (Hycamtin*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.

Official Title
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National, Randomized, Phase II Study Comparing Efficacy of Weekly Administration of Paclitaxel in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Malignant Tumor of Peritoneum

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Topotecan
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged > 18 Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum Peritoneal and/or nodes and/or visceral metastases Disease in progression under treatment or within 6 months after a first or second platinum-based line A period of 3 weeks between last chemotherapy and inclusion Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) ECOG performance status < 2 Life expectancy of at least 12 weeks Exclusion Criteria: Previously received weekly administration of paclitaxel chemotherapy Involved in a trial within the last 30 days Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy Prior diagnosis of malignancy History of ischemic cardiopathy, congestive heart failure (New York Heart Association [NYHA] > 2), arrhythmia, hypertension, or significant valvulopathy Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2 Bone marrow, renal, or hepatic insufficiency Severe active infection or occlusive or sub-occlusive disease History of symptomatic brain metastases Fertile women not using adequate contraceptive methods Pregnant or breast feeding women Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|nan|
|Drug: Topotecan|nan|
|Drug: Carboplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of patients in the three groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Rate of response and rate of progression at the end of treatment |  |  | 
| Qualitative and quantitative toxicities |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapse within 6 months, Previously received taxane derivative