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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
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
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

Further Study Details: 

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


Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting
George Wilding, MD  608-263-8610    gxw@medicine.wisc.edu 

Study chairs or principal investigators

George Wilding, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000353294; WCCC-CO-03904; NCI-6266
Record last reviewed:  August 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079014
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29
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