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MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326456
Recruitment Status : Unknown
Verified July 2017 by National Cancer Institute, Naples.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2006
Last Update Posted : July 17, 2017
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: liposomal doxorubicin Drug: carboplatin Drug: paclitaxel Phase 3

Detailed Description:

Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The high mortality rate is due to the late diagnosis of this malignancy that often develops without symptoms, as well as to limited results in treatment of the disease. Patients may respond well initially to chemotherapy, but the vast majority of patients will experience a progression of the disease. The poor long term results in the standard treatment available today for first-line chemotherapy of ovarian cancer make research into new, more beneficial treatment strategies necessary. The proven efficacy of liposomal doxorubicin in second line treatment, where it is the first drug to have shown some significant benefit in terms of survival, and the possibility of easily combining it with full doses and normal use of carboplatin, encourages the testing of the effectiveness of the combination of carboplatin and liposomal doxorubicin in first line treatment.

Patients enrolled into this study will be randomly assigned to one of two treatment groups:

· Standard therapy consisting of 6 cycles of chemotherapy:

  • carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND
  • paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks


· Experimental therapy consisting of 6 cycles of chemotherapy:

  • carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND
  • liposomal doxorubicin 30 mg/m2 given intravenously on day 1 every 3 weeks

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
Study Start Date : January 2003
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: carboplatin and liposomal doxorubicin Drug: liposomal doxorubicin
30 mg/m2 gieven intravenously on day 1 every 3 weeks

Drug: carboplatin
AUC 5 intravenously on day 1 every 3 weeks

Active Comparator: carboplatin and paclitaxel Drug: carboplatin
AUC 5 intravenously on day 1 every 3 weeks

Drug: paclitaxel
175 mg/m2 intravenously on day 1 every 3 weeks

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 4 years ]
  2. quality of life [ Time Frame: at baseline and every 3 weeks during treatment ]
  3. objective response rate [ Time Frame: at 9 and 18 weeks after starting study therapy ]
  4. toxicity [ Time Frame: every 3 weeks during chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00326456

Show Show 38 study locations
Sponsors and Collaborators
National Cancer Institute, Naples
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Principal Investigator: Sandro Pignata, M.D., Ph.D National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute, Naples
Publications of Results:
Other Publications:
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Responsible Party: National Cancer Institute, Naples Identifier: NCT00326456    
Other Study ID Numbers: MITO-2
2005-004453-98 ( EudraCT Number )
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Keywords provided by National Cancer Institute, Naples:
ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors