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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SINGLE ARM

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Interventions

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carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No