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| Sponsor: | Wake Forest University Baptist Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT00007943 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have advanced colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer |
| Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1
prior course of fluoropyrimidine-based chemotherapy
Measurable and/or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | Paul D. Savage, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000068355, CCCWFU-59198, NCI-914 |
| Study First Received: | January 6, 2001 |
| Last Updated: | August 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00007943 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III colon cancer stage IV colon cancer stage III rectal cancer |
stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Therapeutic Uses Gemcitabine |
Digestive System Neoplasms Enzyme Inhibitors Intestinal Diseases Antiviral Agents Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Colorectal Neoplasms |