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

National Cancer Institute, Naples

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00401674

MITO-5

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

Female

Ages

70+ years old

Volunteers

No Healthy Volunteers

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