A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.

Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

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

Details

• Lead Sponsor: Nordic Society for Gynaecologic Oncology; Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

• Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.

• Female

• age above 18 years

• WHO performance status 0-2

• Life expectancy > 3 months

• Previous treatment with one platinum and taxane containing regimen.

• Platinum and taxane sensitive relapse

• At least one evaluable/measurable lesion.

• Adequate hematologic, renal and liver function

• Consent form signed and dated before inclusion

Exclusion Criteria:

• Prior treatment with more than one line of chemotherapy

• Concurrent severe and/or uncontrolled co-morbid medical condition.

• History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock

• Pregnant or lactating women (or potentially fertile women not using adequate contraception)

• Peripheral neuropathy > Grade 2

• History of allergy to drugs containing the excipient TWEEN 80®.

• Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy

• Clinical evidence of brain metastases