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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Topotecan

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