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

National Cancer Institute, Naples26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

carboplatinDRUG

paclitaxelDRUG

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (10)

Ospedale Fatebenefratelli, U.O. di Oncologia

Benevento, BN, Italy

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia

Campobasso, CB, Italy

Ospedale Cannizzaro

Cannizzaro, CT, Italy

Outcomes

Primary Outcomes

Objective response rate

Time frame: 6 month

Toxicity

assessed weekly

Time frame: up to 6 months

Secondary Outcomes

possible predictive factors of the geriatric ADL and IADL scales

Time frame: 6 months

Data from ClinicalTrials.gov

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