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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar S.A. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00113607 |
This study tests the safety and effectiveness of a YONDELIS® (trabectedin) and DOXIL/CAELYX (herein referred to as DOXIL) combination to DOXIL alone.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: DOXIL Drug: trabectedin + DOXIL |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | May 2011 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: trabectedin + DOXIL
Trabectedin 1.1 mg/m² as a 3 hour infusion + DOXIL 30 mg/m² every 3 weeks
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002: Active Comparator |
Drug: DOXIL
50 mg/m² every 4 weeks
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This is a multicenter, open-label, randomized, Phase 3 study comparing the combination of Doxil, 30mg/m2, administered as a 90-minute infusion followed by trabectedin, 1.1 mg/m2 3-hour infusion, every 3 weeks with DOXIL, 50 mg/m2 as a 90-minute infusion every 4 weeks, in previously treated patients with advanced ovarian cancer for whom first-line platinum-based chemotherapy regimen has failed. The purpose of this research study is to determine if the combination of trabectedin and DOXIL is better at improving progression free survival over DOXIL alone in patients with relapsed advanced ovarian cancer. Additional comparisons between the two treatment groups include: overall survival, measurement of disease progression, response rate, (how much your tumor shrinks in response to the drug) safety, pharmacokinetics (measuring the amount of drug in your body), quality of life, and optional measurement of circulating tumor cells if present. Patients may receive either a combination of trabectedin and DOXIL (Group A) or DOXIL alone (Group B). If you are in Group A you will receive dexamethasone followed by Trabectedin 1.1 mg/m² as a 3 hour infusion + DOXIL 30 mg/m² every 3 weeks as long as you are responding to treatment. If you are in Group B you will receive DOXIL 50 mg/m2 every 4 weeks as long as you are responding to treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Director ) |
Study ID Numbers: | CR003448, ET743-OVA-301 |
Study First Received: | June 9, 2005 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00113607 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Trabectedin Yondelis Ovarian cancer |
Ecteinascidin 743 Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Doxorubicin |
Genital Diseases, Female Anti-Bacterial Agents Ovarian Cancer Antineoplastic Agents, Alkylating Endocrinopathy Alkylating Agents Endocrine Gland Neoplasms |
Ecteinascidin 743 Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic |
Pharmacologic Actions Doxorubicin Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Endocrine Gland Neoplasms |