Home
Search
Study Topics
Glossary
|
Study 15 of 493 for search of: | Australia, South Australia |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsored by: |
National Cancer Institute of Canada |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026338 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, extent of disease (locally advanced vs metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.
Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent courses, at 4 weeks after study, and then every 12 weeks until disease progression.
Patients are followed at 4 weeks and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 11 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
No post-surgical malabsorption characterized by:
Ophthalmic:
No significant ophthalmologic abnormalities, including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Malcolm J. Moore, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000069020, CAN-NCIC-PA3, OSI-CAN-NCIC-PA3 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026338 |
Health Authority: | United States: Federal Government |
stage III pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Erlotinib Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Adenocarcinoma Pancrelipase Endocrine Gland Neoplasms |
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 |