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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00040820 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.
Condition | Intervention |
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Colorectal Cancer |
Drug: oxaliplatin |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients |
Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, Treatment Access Program study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 30 days.
PROJECTED ACCRUAL: Approximately one patient per site per month will be accrued for this study.
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 amenable to surgical resection or other potentially curative therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Milind Javle, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000069410, RPCI-DS-0130, SANOFI-LTS7072B, NCI-G02-2081 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00040820 |
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 adenocarcinoma of the colon adenocarcinoma of the rectum |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |