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3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors
This study is currently recruiting patients.
Sponsored by: | University of Wisconsin Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help doxorubicin kill more cancer cells by making them more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with doxorubicin in treating patients who have metastatic or refractory solid tumors.
Condition | Treatment or Intervention | Phase |
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unspecified adult solid tumor, protocol specific |
Drug: 3-AP Drug: doxorubicin Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: enzyme inhibitor therapy |
Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 3-AP (Triapine®) and Doxorubicin in Patients With Metastatic or Refractory Solid Tumors
OBJECTIVES: Primary
Secondary
OUTLINE: This is a dose-escalation study of 3-AP (Triapine^®).
Patients receive doxorubicin IV over 15 minutes on day 1 and 3-AP (Triapine®) IV over 2 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 6 patients are treated at that dose level.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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