MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.

The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.

This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

Inclusion Criteria:

• Age 70 years or greater
• Cytologic / histologic diagnosis ovarian cancer
• Stage of disease at diagnosis IC -IV
• Performance status (ECOG) < 3
• Indication for chemotherapy treatment
• Written informed consent

Exclusion Criteria:

• Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
• Cerebral metastases
• Neutrophils < 1000/mm3, platelets < 100000/mm3, hemoglobin < 8g/dl
• Creatinine > o = 1.25 times the upper normal limit
• GOT or GPT > o = 1.25 times the upper normal limit, except in case of liver metastases)
• Patient's inability to comply with followup