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

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: carboplatin; Drug: paclitaxel

• Registration Number: NCT00401674
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SINGLE ARM	paclitaxel	-
SINGLE ARM	carboplatin	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	6 month
Toxicity	up to 6 months	assessed weekly

Secondary Outcome Measures

Name	Time	Method
possible predictive factors of the geriatric ADL and IADL scales	6 months

Trial Locations

Locations (10)

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B; 🇮🇹 Napoli, Italy

Ospedale S. Giovanni Calibita Fatebenefratelli; 🇮🇹 Roma, Italy

Università Cattolica del Sacro Cuore, Dipartimento di Oncologia; 🇮🇹 Campobasso, CB, Italy

Ospedale S. Massimo; 🇮🇹 Penne, PE, Italy

Ospedale Fatebenefratelli, U.O. di Oncologia; 🇮🇹 Benevento, BN, Italy

Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica; 🇮🇹 Vicenza, VI, Italy

Ospedale Cannizzaro; 🇮🇹 Cannizzaro, CT, Italy

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia; 🇮🇹 Mantova, MN, Italy

Ospedale Civile Umberto I, Day Hospital Oncoematologico; 🇮🇹 Nocera Inferiore, SA, Italy