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Sponsored by: |
ImClone LLC |
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Information provided by: | ImClone LLC |
ClinicalTrials.gov Identifier: | NCT00870870 |
The purpose of this study is to determine the number of patients whose cancer shrinks or disappears after treatment on the study.
Condition | Intervention | Phase |
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Non-small Cell Lung Cancer |
Biological: Cetuximab Drug: Gemcitabine Drug: Carboplatin Biological: IMC-A12 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Gemcitabine, Carboplatin, Cetuximab + A12: Experimental
Patients in this arm will receive the following treatment schedule for the first 6 cycles: Cetuximab: 400mg/m2 on Day 1 of cycle 1; 250 mg/m2 once per week thereafter Gemcitabine: 1000mg/m2 on Days 1 and 8 of each cycle Carboplatin: AUC = 5, Day 1 of each cycle IMC-A12: 6mg/kg once per week (on Days 1, 8 and 15 of each cycle) Then for the maintenance period: Cetuximab: 500mg/m2 once every 2 weeks IMC-A12: 10mg/kg once every 2 weeks |
Biological: Cetuximab
400 mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter.
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of each cycle
Drug: Carboplatin
AUC = 5, Day 1 of each cycle
Biological: IMC-A12
6 mg/kg once per week (on Days 1, 8, and 15 of each cycle)
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Gemcitabine, Carboplatin, Cetuximab: Active Comparator
Patients on this arm will receive the following treatment schedule for the first 6 cycles: Cetuximab: 400mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter. Gemcitabine: 1000mg/m2 on Days 1 and 8 of each cycle Carboplatin: AUC = 5, Day 1 of each cycle Then during the maintenance period: Cetuximab: 500mg/m2 once every two weeks |
Biological: Cetuximab
400 mg/m2 on Day 1 of Cycle 1; 250 mg/m2 once per week thereafter.
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of each cycle
Drug: Carboplatin
AUC = 5, Day 1 of each cycle
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Stratified, randomized, multicenter, open-label Phase 2 study of 80 patients with Stage IIIb or IV NSCLC who have not received previous chemotherapy in the metastatic setting. Patients will be stratified based on disease histology (squamous versus [vs.] nonsquamous), and randomized on a 1:1 basis to receive gemcitabine, carboplatin, cetuximab, and IMC-A12 (GCC + A12) or gemcitabine, carboplatin, and cetuximab (GCC).
A treatment cycle will be defined as 3 weeks for the first 18 weeks; a cycle will be defined as 2 weeks thereafter. Combination therapy will continue for a total of six 3-week cycles (18 weeks), after which patients will enter a maintenance phase.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricia Kellerhouse, BS | 908 541 8250 | patricia.kellerhouse@imclone.com |
United States, Florida | |
M.D. Anderson Cancer Center Orlando | Recruiting |
Orlando, Florida, United States, 32806 | |
Principal Investigator: Jennifer E Tseng, MD | |
United States, Georgia | |
Georgia Cancer Specialists | Recruiting |
Atlanta, Georgia, United States, 30341 | |
Principal Investigator: Mansoor Saleh, MD | |
United States, New Mexico | |
University of New Mexico Cancer Treatment Center | Recruiting |
Albuquerque, New Mexico, United States, 87131 | |
Principal Investigator: Julie Bauman, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Emily Wang 646-227-2820 wange@mskcc.org | |
Principal Investigator: Naiyer Rizvi, MD |
Responsible Party: | ImClone LLC ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | CP13-0811 |
Study First Received: | March 26, 2009 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00870870 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tumors Antibodies, Monoclonal Stage IIIb Metastatic Non-Small Cell Lung Cancer Stage IV Metastatic Non-Small Cell Lung Cancer |
Antimetabolites Thoracic Neoplasms Anti-Infective Agents Immunologic Factors Cetuximab Carboplatin Immunosuppressive Agents Antiviral Agents Carcinoma Antibodies, Monoclonal |
Antibodies Radiation-Sensitizing Agents Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Immunoglobulins Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Cetuximab Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |