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Sponsored by: |
National Cancer Institute, Naples |
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Information provided by: | National Cancer Institute, Naples |
ClinicalTrials.gov Identifier: | NCT00326456 |
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 |
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Ovarian Cancer |
Drug: liposomal doxorubicin Drug: carboplatin Drug: paclitaxel |
Phase III |
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 |
Estimated Enrollment: | 820 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | January 2008 |
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:
OR
Experimental therapy consisting of 6 cycles of chemotherapy:
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Sandro Pignata, M.D., Ph.D | National Cancer Institute, Naples |
Principal Investigator: | Francesco Perrone, M.D., Ph.D | National Cancer Institute, Naples |
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 |
ovarian cancer chemotherapy first-line |
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 |
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 |