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

Phase 2

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Malignant Tumor of Peritoneum

• Registration Number: NCT00189566
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2009-04
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free survival of patients in the three groups

Secondary Outcome Measures

Name	Time	Method
Overall survival
Rate of response and rate of progression at the end of treatment
Qualitative and quantitative toxicities
Quality of life

Trial Locations

Locations (1)

Hôpital Hotel Dieu; 🇫🇷 Paris, France