Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer (MITO-7)

National Cancer Institute, Naples

Status and phase: Active, not recruiting; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: paclitaxel; Drug: carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00660842

MITO-7

2008-001754-40 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

Full description

The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage IC-IV
• Indication for chemotherapy
• Age > 18 years
• Life expectancy of at least 3 months

Exclusion criteria

• Previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma Stage Ib or less for the uterus, with ovarian tumor Stage II or higher)
• Performance Status (ECOG) > or = 3.
• Previous chemotherapy
• Heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias)
• Neutrophils < 2000 x mm3, platelets < 100000 x mm3
• Inadequate renal function (creatinine > or = 1.25 x normal values) or liver function (ALT or AST > or = 1.25 x normal values)
• Present or suspected hemorrhagic syndromes
• Inability to comply with protocol and follow-up
• Inability to access study site for clinical visits
• Refusal of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

A

Experimental group

Description:

weekly chemotherapy

Treatment:

Drug: carboplatin

Drug: paclitaxel

Drug: paclitaxel

Drug: carboplatin

B

Active Comparator group

Description:

every 3 weeks chemotherapy

Treatment:

Drug: paclitaxel

Drug: paclitaxel