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Sponsors and Collaborators: |
Institute for Drug Development National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101348 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with cetuximab and/or bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of erlotinib and bevacizumab when given with cetuximab and how well giving erlotinib and cetuximab together with or without bevacizumab works in treating patients with metastatic or unresectable kidney, colorectal, head and neck, pancreatic, or non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Head and Neck Cancer Kidney Cancer Lung Cancer Pancreatic Cancer |
Drug: bevacizumab Drug: cetuximab Drug: erlotinib hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I and Biologic Correlative Study of Erlotinib, in Combination With Cetuximab and Bevacizumab in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 66 |
Study Start Date: | January 2005 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib and bevacizumab.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
In both groups, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 66 patients will be accrued within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Renal cell cancer
Metastatic or unresectable disease AND meets 1 of the following criteria:
Colorectal, head and neck, pancreatic, or non-small cell lung cancer
No evidence of CNS disease, including the following (part 2 only):
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following are allowed for part 2:
Gastrointestinal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Concurrent full-dose anticoagulants allowed provided the following criteria are met (part 2 only):
United States, Texas | |
Brooke Army Medical Center | |
Fort Sam Houston, Texas, United States, 78234-6200 | |
Institute for Drug Development | |
San Antonio, Texas, United States, 78245-3217 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Alain Mita, MD | Institute for Drug Development |
Study ID Numbers: | CDR0000401514, CTRC-IDD-0332, NCI-6588 |
Study First Received: | January 7, 2005 |
Last Updated: | August 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00101348 |
Health Authority: | United States: Food and Drug Administration |
recurrent pancreatic cancer stage III pancreatic cancer recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer recurrent adenoid cystic carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent basal cell carcinoma of the lip stage III basal cell carcinoma of the lip stage IV basal cell carcinoma of the lip recurrent mucoepidermoid carcinoma of the oral cavity |
stage III mucoepidermoid carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage III verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx |
Thoracic Neoplasms Rectal Neoplasms Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Bevacizumab Urologic Neoplasms Rectal Diseases Dental Caries Carcinoma, Adenoid Cystic Lung Neoplasms Metastatic squamous neck cancer with occult primary Laryngeal carcinoma Kidney Diseases Salivary Gland Diseases |
Rectal cancer Endocrine Gland Neoplasms Erlotinib Non-small cell lung cancer Digestive System Neoplasms Endocrine System Diseases Carcinoma, Basal Cell Renal cancer Carcinoma Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoma, Squamous Cell Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |