Status:
COMPLETED
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
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-I...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00401674
Start Date
June 1 2003
End Date
June 1 2008
Last Update
January 14 2016
Active Locations (10)
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1
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
2
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia
Campobasso, CB, Italy, 86100
3
Ospedale Cannizzaro
Cannizzaro, CT, Italy
4
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia
Mantova, MN, Italy, 46100