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| Sponsor: | ImClone LLC |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | ImClone LLC |
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 39 |
| Study Start Date: | September 2003 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Biological: Cetuximab:
400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles
Other Name: Erbitux
Drug: Paclitaxel
175 mg/m2 Day 1, six 21-day cycles
Drug: Carboplatin
AUC = 6 Day1, six 21-day cycles
|
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 | |
| ImClone Investigational Site | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| ImClone Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Study Director: | E-mail: ClinicalTrials@ ImClone.com | ImClone LLC |
More Information
| Responsible Party: | Chief Medical Officer, ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00063401 History of Changes |
| Obsolete Identifiers: | NCT00070044 |
| Other Study ID Numbers: | CA225-009 |
| Study First Received: | June 25, 2003 |
| Last Updated: | April 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian primary peritoneal cancer fallopian tube cancer |
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Cetuximab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |