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

ARCAGY/ GINECO GROUP1 site in 1 country165 target enrollmentApril 2004

ConditionsOvarian Cancer Fallopian Tube Cancer Malignant Tumor of Peritoneum

DrugsPaclitaxel Topotecan Carboplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: ARCAGY/ GINECO GROUP
Enrollment: 165
Locations: 1
Primary Endpoint: Progression-free survival of patients in the three groups
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

April 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

ARCAGY/ GINECO GROUP

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