Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
18 Years
N/A
Female
Ovarian Cancer
Trial Information
Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
quality of life
Outcome Time Frame:
weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy
Safety Issue:
No
Principal Investigator
Sandro Pignata, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute, Naples
Authority:
Italy: Ethics Committee
Study ID:
MITO-7
NCT ID:
NCT00660842
Start Date:
November 2008
Completion Date:
December 2012
Related Keywords:
- Ovarian Cancer
- quality of life
- weekly therapy
- neurotoxicity
- Ovarian Neoplasms
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