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

A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer

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.

Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

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