Clinical trial · Interventional
MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
NCT00326456CI-TRIAL-00065031unknownPhase 3ClinicalTrials.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 compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer. Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| liposomal doxorubicin | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- carboplatin and liposomal doxorubicin
- interventionNames
- Drug: liposomal doxorubicin
- Drug: carboplatin
- type
- ACTIVE_COMPARATOR
- label
- carboplatin and paclitaxel
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- at 2 years
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologic / histologic diagnosis of stage Ic-IV ovarian cancer * Indication for chemotherapy treatment * Age 75 years or less * Life expectancy of at least 3 months 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) * Performance status (ECOG) \> 2 * Previous chemotherapy treatment * Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia) * Leukocytes \< 4000/mm3, neutrophils \< 2000/mm3, platelets \< 100000/mm3 * Impaired renal function (creatinine \> 1.25 times the upper normal limit) or liver function (SGOT or SGPT \> 1.25 times the upper normal limit) * Present or suspected hemorrhagic syndromes * Uncooperative and/or unreliable patients * Patient's inability to access the center * Refusal of informed consent
References
Publications (3)
- BACKGROUNDPignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, Rossi E, Gebbia V, Natale D, Del Gaizo F, Naglieri E, Ferro A, Musso P, D'Arco AM, Sorio R, Pisano C, Di Maio M, Signoriello G, Annunziata A, Perrone F; MITO Investigators. Safety of a 3-weekly schedule of carboplatin plus pegylated liposomal doxorubicin as first line chemotherapy in patients with ovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer. 2006 Aug 1;6:202. doi: 10.1186/1471-2407-6-202. PMID 16882344
- BACKGROUNDPignata S, Scambia G, Savarese A, Breda E, Sorio R, Pisano C, Lorusso D, Cognetti F, Vernaglia Lombardi A, Gebbia V, Scollo P, Morabito A, Signoriello G, Perrone F. Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer: preliminary activity results of the MITO-2 phase III trial. Oncology. 2009;76(1):49-54. doi: 10.1159/000178760. Epub 2008 Nov 27. PMID 19039248
- RESULTPignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, Gebbia V, Musso P, Frigerio L, Del Medico P, Lombardi AV, Febbraro A, Scollo P, Ferro A, Tamberi S, Brandes A, Ravaioli A, Valerio MR, Aitini E, Natale D, Scaltriti L, Greggi S, Pisano C, Lorusso D, Salutari V, Legge F, Di Maio M, Morabito A, Gallo C, Perrone F. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol. 2011 Sep 20;29(27):3628-35. doi: 10.1200/JCO.2010.33.8566. Epub 2011 Aug 15. PMID 21844495