Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
Phase 2
70 Years
N/A
70 Years
N/A
Not Enrolling
Female
Ovarian Cancer
Female
Ovarian Cancer
Trial Information
Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
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-5
NCT ID:
NCT00401674
Start Date:
June 2003
Completion Date:
June 2008
Related Keywords:
- Ovarian Cancer
- ovarian cancer
- elderly
- weekly chemotherapy
- first-line
- Ovarian Neoplasms
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