Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00032110 |
RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or metastatic colorectal cancer.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study Of OSI-774 In Metastatic Colorectal Cancer |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after CR is confirmed.
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 4-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not curable with conventional therapy
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Gastrointestinal:
Ophthalmic:
No abnormalities of the cornea:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent warfarin
Canada, Ontario | |
Cancer Care Ontario-Hamilton Regional Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 |
Study Chair: | Amit M. Oza, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000069258, PMH-PHL-003, NCI-5378 |
Study First Received: | March 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00032110 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Erlotinib Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |