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| Sponsors and Collaborators: |
ImClone Systems Bristol-Myers Squibb |
| Information provided by: | ImClone Systems |
| ClinicalTrials.gov Identifier: | NCT00063401 |
Purpose
The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.
| Condition | Intervention | Phase |
|
Ovarian Cancer Peritoneal Neoplasms Fallopian Tube Neoplasms |
Biological: Cetuximab: Drug: Paclitaxel Drug: Carboplatin |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| Drug Information available for: | Carboplatin Paclitaxel Cetuximab Epidermal Growth Factor |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer |
| Estimated Enrollment: | 39 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Cetuximab 400 mg/m2 IV (over 120 minutes) on Day 1 of Cycle 1, followed by weekly maintenance doses of 250 mg/m2 IV (over 60 minutes). Paclitaxel 175 mg/m2 IC (over 3 hours) and carboplatin AUC of 6 IV (over 30 minutes) on Day 1 of each cycle. For eligible subjects, maintenance therapy will consist of cetuximab 250 mg/m2/week for up to 6 months.
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Biological: Cetuximab:
400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
Drug: Paclitaxel
175 mg/m2 Day 1, six 21-day cycles
Drug: Carboplatin
AUC = 6 Day1, six 21-day cycles
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The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled. By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| ImClone Systems |
| Bristol-Myers Squibb |
| Study Chair: | Carol Aghajanian, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
| Study ID Numbers: | CA225009 |
| First Received: | June 25, 2003 |
| Last Updated: | October 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00063401 |
| Health Authority: | United States: Food and Drug Administration |
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