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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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