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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00090610 |
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: Taxotere® Drug: Carboplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Phase III Comparative Study to Compare the Efficacy and Safety of Taxotere®/Carboplatin Combination Therapy Versus Sequential Therapy With Taxotere® Then Carboplatin as Second-Line Treatment of Patients With Relapsed, Platinum-Sensitive Ovarian Cancer |
Estimated Enrollment: | 250 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | October 2005 |
Primary Objective
The primary objective of the study is to compare the progression-free survival of two treatment regimens:
Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator’s discretion.)
Versus
Taxotere® 30 mg/m2 IV on Days 1 and 8, repeated every 21 days up to 6 cycles or until disease progression. Followed by carboplatin (AUC 6) IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere®. A patient who has achieved a complete response on Taxotere® will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin. Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression. (A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator’s discretion.)
Secondary Objectives
The secondary objectives of the study are to compare the objective response rates (defined as a complete response plus partial response), duration of tumor response, median survival, QOL and safety in patients treated with the two regimens described above.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has received one and only one prior chemotherapy regimen for the treatment of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is allowed. Patients who have received consolidation treatment are allowed. Prior treatment with Taxotere® is not allowed.
o Consolidation therapy is allowed including a different cytotoxic agent than the agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and immunotherapy.
Exclusion Criteria:
Contact: Amy Evans, BS, MT | 910-772-6718 | amy.evans@wilm.ppdi.com |
Contact: Pat Wood, RN | 910-772-7553 | patricia.wood@wilm.ppdi.com |
Study Chair: | Angeles A Secord, MD | Duke University |
Study ID Numbers: | DUMC03, DUKE UNIVERSITY MEDICAL CENTER, CLINICAL STUDY PROTOCOL |
Study First Received: | August 27, 2004 |
Last Updated: | June 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00090610 |
Health Authority: | United States: Food and Drug Administration |
Relapsed ovarian cancer |
Docetaxel Genital Diseases, Female Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Carboplatin Endocrinopathy Ovarian Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Adnexal Diseases |