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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00062127 |
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.
Combining thalidomide with irinotecan may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: irinotecan hydrochloride Drug: thalidomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase I Pharmacokinetic Interaction Study of Irinotecan (NSC616348) and Thalidomide (NSC66847) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 35 |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 35 patients 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 confirmed malignant solid tumor
No uncontrolled brain metastases
Patients with brain metastases are eligible provided the following are true:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Apurva Desai | University of Chicago |
Study ID Numbers: | CDR0000304517, UCCRC-12044B, NCI-5814 |
Study First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00062127 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Anti-Infective Agents Anti-Bacterial Agents Immunologic Factors Thalidomide Irinotecan |
Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors Immunosuppressive Agents Camptothecin |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Irinotecan Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Angiogenesis Inhibitors Camptothecin Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Leprostatic Agents |