Clinical trial · Interventional
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer
Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.
NCT00401674CI-TRIAL-00020540MITO-5completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SINGLE ARM
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- 6 month
- measure
- Toxicity
- timeFrame
- up to 6 months
- description
- assessed weekly
Secondary outcomes (1)
- measure
- possible predictive factors of the geriatric ADL and IADL scales
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPignata S, Breda E, Scambia G, Pisano C, Zagonel V, Lorusso D, Greggi S, De Vivo R, Ferrandina G, Gallo C, Perrone F. A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study. Crit Rev Oncol Hematol. 2008 Jun;66(3):229-36. doi: 10.1016/j.critrevonc.2007.12.005. Epub 2008 Feb 1. PMID 18243011