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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033241 |
RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advanced Pancreatic Carcinoma Or Other Potentially Responsive Malignancies |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated at the MTD as above.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic epithelial carcinoma of the pancreas or other malignancy considered to be potentially responsive to gemcitabine
No active CNS metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
No significant gastrointestinal abnormalities including:
Ophthalmic:
No significant ophthalmologic abnormalities including:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Other concurrent endocrine therapy is allowed as follows:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |
Arizona Cancer Center at University of Arizona Health Sciences Center | |
Tucson, Arizona, United States, 85724 | |
United States, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229-3271 |
Study Chair: | Pedro Santabarbara, MD | OSI Pharmaceuticals |
Study ID Numbers: | CDR0000069266, OSI-774-155, UARIZ-HSC-01128, NCI-V02-1694 |
Study First Received: | April 9, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00033241 |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer unspecified adult solid tumor, protocol specific stage IV pancreatic cancer |
Erlotinib Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Recurrence Endocrine Gland Neoplasms Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |