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

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Conditions

Malignant Tumor of Peritoneum

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: Carboplatin

Drug: Paclitaxel

Drug: Topotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00189566

CAR\TAXHY

Details and patient eligibility

About

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.

Full 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.

Enrollment

165 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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