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Sponsors and Collaborators: |
University of Colorado at Denver and Health Sciences Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00778167 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib is more effective when given together with or without IMC-A12 in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects and best dose of IMC-A12 and to see how well erlotinib works when given together with or without IMC-A12 in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: cixutumumab Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Phase II Cross Over Study With a Safety Lead In of the Anti-IGF-1R Monoclonal Antibody IMC-A12 in Combination With Erlotinib Compared With Erlotinib Alone in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Failed At Least One Platinum Containing Chemotherapy Regimen. |
Estimated Enrollment: | 120 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oral erlotinib hydrochloride once daily on days 1-28.
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Drug: erlotinib hydrochloride
Given orally
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Arm II: Experimental
Patients receive oral erlotinib hydrochloride as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour on days 1, 8, 15, and 22.
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Drug: cixutumumab
Given IV
Drug: erlotinib hydrochloride
Given orally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
PATIENT CHARACTERISTICS:
No poorly controlled diabetes mellitus
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Colorado | |
University of Colorado Cancer Center at UC Health Sciences Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650 | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 |
Study Chair: | David R. Camidge, MD, PhD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | CDR0000617094, UCHSC-08-0044 |
Study First Received: | October 22, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00778167 |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Erlotinib Antibodies, Monoclonal Thoracic Neoplasms Antibodies Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Immunoglobulins Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |