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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082771 |
RATIONALE: SU011248 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well SU011248 works in treating patients with metastatic colorectal adenocarcinoma (cancer) that has not responded to previous treatment with irinotecan, oxaliplatin, and a fluoropyrimidine (such as fluorouracil) with or without bevacizumab.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And Fluoropyrimidine, With And Without Bevacizumab |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior bevacizumab (yes vs no).
Patients receive oral SU011248 once daily on days 1-28. Courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30 days and then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 76-126 patients (38-63 per stratum) 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:
Must have received prior irinotecan, oxaliplatin, and a fluoropyrimidine in the adjuvant and/or advanced disease setting with or without bevacizumab (in the advanced disease setting) AND developed resistance to these prior therapies, as defined by one of the following:
At least one unidimensionally measurable lesion at least 20 mm by conventional radiographic techniques or MRI OR at least 10-16 mm by spiral CT scan
The following lesions are not considered measurable:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following conditions within the past 12 months:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
At least 3 weeks since prior radiotherapy and recovered
No concurrent radiotherapy to the sole site(s) of measurable disease
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000360732, MSKCC-03143, PFIZER-A6181003, PFIZER-PHA-RTKC-0511 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082771 |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum recurrent colon cancer recurrent rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms |
Rectal neoplasm Carcinoma Oxaliplatin Digestive System Diseases Sunitinib Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |