Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

3-AP and Doxorubicin In Treating Patients With Metastatic or Refractory Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCI WCCC-CO-03904 NCI-6266

Objectives

Primary

1. Determine the maximum tolerated dose of 3-AP (Triapine^®) when administered with doxorubicin in patients with metastatic or refractory solid tumors.

Secondary

1. Determine the toxicity profile of this regimen in these patients.
2. Determine any antitumor activity of this regimen in these patients.
3. Determine the pharmacokinetic profile of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed solid tumor
  • Metastatic or unresectable disease



• Measurable or evaluable disease



• Not amenable to available standard curative or palliative chemotherapy



• No known brain metastasis

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior anthracyclines

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of bone marrow

Surgery

• Not specified

Other

• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• WBC ≥ 3,000/mm³
• No G6PD deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)

Hepatic

• AST/ALT ≤ 2.5 times upper limit of normal
• Bilirubin normal

Renal

• Creatinine ≤ 1.5 mg/dL

  OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• LVEF > 45%
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• Oxygen saturation 95-100%
• No severe pulmonary disease requiring oxygen therapy

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study treatment
• No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP (Triapine®) or any other study agent
• No other concurrent uncontrolled illness
• No active or ongoing infection
• No psychiatric illness or social situation that would preclude study compliance

Projected Accrual

A total of 3-36 patients will be accrued for this study.

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Comprehensive Cancer Center

George Wilding, MD, Protocol chair		Ph: 608-263-8610; 800-622-8922 Email: gxw@medicine.wisc.edu

U.S.A.
Wisconsin
	Madison
	University of Wisconsin Comprehensive Cancer Center
		George Wilding, MD	Ph:  608-263-8610 800-622-8922
			Email: gxw@medicine.wisc.edu

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