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MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
This study is ongoing, but not recruiting participants.
First Received: May 15, 2006   Last Updated: November 15, 2007   History of Changes
Sponsored by: National Cancer Institute, Naples
Information provided by: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00326456
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: liposomal doxorubicin
Drug: carboplatin
Drug: paclitaxel
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Paclitaxel Carboplatin Myocet
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • Progression free survival

Secondary Outcome Measures:
  • overall survival
  • quality of life
  • objective response rate
  • toxicity

Estimated Enrollment: 820
Study Start Date: January 2003
Estimated Study Completion Date: January 2008
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

OR

  • 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
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326456

  Show 38 Study Locations
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Sandro Pignata, M.D., Ph.D National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute, Naples
  More Information

Publications:
Study ID Numbers: MITO-2, EudraCT number 2005-004453-98
Study First Received: May 15, 2006
Last Updated: November 15, 2007
ClinicalTrials.gov Identifier: NCT00326456     History of Changes
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
ovarian cancer
chemotherapy
first-line

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin
Doxorubicin
Genital Diseases, Female
Anti-Bacterial Agents
Paclitaxel
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009