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

NCT ID: NCT00189566

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2009-04-30

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Malignant Tumor of Peritoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paclitaxel

Intervention Type: DRUG

Topotecan

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: lead

Principal Investigators

Laure Chauvenet, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Hôtel Dieu

Locations

Hôpital Hotel Dieu

Paris, , France

Countries

France

Other Identifiers

CAR\TAXHY

Identifier Type: -

Identifier Source: org_study_id