Ovarian Cancer Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 165 |
Est. completion date | April 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Hotel Dieu | Paris |
Lead Sponsor | Collaborator |
---|---|
ARCAGY/ GINECO GROUP |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival of patients in the three groups | |||
Secondary | Overall survival | |||
Secondary | Rate of response and rate of progression at the end of treatment | |||
Secondary | Qualitative and quantitative toxicities | |||
Secondary | Quality of life |
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