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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030498 |
Purpose
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: erlotinib hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of OSI-774 (NSC 718781) for Solid Tumors in Patients With Hepatic or Renal Dysfunction |
| Study Start Date: | December 2001 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to hepatic or renal dysfunction (albumin less than 2.5 g/dL, direct bilirubin less than 1.0 mg/dL, any AST, and creatinine normal vs direct bilirubin 1.0-7.0 mg/dL, any AST, and creatinine normal vs creatinine 2.5-5.0 mg/dL, albumin 2.5 g/dL or greater, AST less than 3 times upper limit of normal, and direct bilirubin less than 1.0 mg/dL).
Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.
PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies:
Hepatic or renal dysfunction defined as one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Ophthalmic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| Study Chair: | Antonius A. Miller, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000069170, CALGB-60101 |
| Study First Received: | February 14, 2002 |
| Last Updated: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030498 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV breast cancer recurrent breast cancer recurrent non-small cell lung cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer stage IV ovarian epithelial cancer |
recurrent ovarian epithelial cancer recurrent adult brain tumor recurrent bladder cancer stage IV bladder cancer stage IV prostate cancer recurrent prostate cancer adult brain stem glioma stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity |
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Glioblastoma Laryngeal Carcinoma Carcinoma, Hepatocellular Rectal Neoplasms Pancreatic Neoplasms Esophageal Neoplasms Breast Cancer, Male Anal Cancer Squamous Cell Carcinoma Protein Kinase Inhibitors Ependymoma Hypopharyngeal Cancer Liver Neoplasms Carcinoma, Adenoid Cystic Lung Neoplasms |
Bladder Neoplasm Glioma Hepatocellular Carcinoma Papilloma Salivary Gland Diseases Erlotinib Nasopharyngeal Carcinoma Astrocytoma Rectal Neoplasm Urinary Bladder Neoplasms Breast Neoplasms Esophageal Cancer Carcinoma, Basal Cell Ovarian Epithelial Cancer Granuloma |
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Erlotinib Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |