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| Sponsor: | US Oncology Research |
|---|---|
| Collaborators: |
ImClone LLC Sanofi-Aventis |
| Information provided by: | US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT00517829 |
Purpose
The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Gastric or GEJ Cancer |
Drug: Docetaxel + oxaliplatin Drug: Docetaxel + oxaliplatin + cetuximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Taxotere as an intravenous (IV) infusion over 1 hour, followed by Eloxatin IV over 2 hours
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Drug: Docetaxel + oxaliplatin
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours
Other Names:
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Active Comparator: 2
Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130 mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
|
Drug: Docetaxel + oxaliplatin + cetuximab
Taxotere 60 mg/m2 as an IV infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
Other Names:
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This is a Phase II, open- label, randomized, noncomparative study. Patients will be stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS.
Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 - Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle.
Treatment will continue until disease progression or intolerable toxicity. Patients who achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to 24 months of participation, counted from the date of the first dose of study drug.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
Exclusion Criteria:
Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
Contacts and Locations
Show 47 Study Locations| Principal Investigator: | Donald A Richards, MD | US Oncology Research |
More Information
| Responsible Party: | Debra Bailey, RN, US Oncology Research |
| ClinicalTrials.gov Identifier: | NCT00517829 History of Changes |
| Other Study ID Numbers: | 06063 |
| Study First Received: | August 15, 2007 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Oxaliplatin Docetaxel Cetuximab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |