Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry 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 Completed 18 and over NCI WCCC-CO-03904 NCI-6266, NCT00079014, 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) during course 1 of study treatment
  • Concurrent G-CSF and GM-CSF allowed during subsequent courses at the discretion of the principal investigator

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 (i.e., ≥ lower limit of normal)

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
• No toxicity > grade 1 from prior therapy

Expected Enrollment

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

Outcomes

Maximum tolerated dose at first course

Toxicity at first and second course
Antitumor activity at first and second course

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.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

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

Registry Information
Official Title		A Phase I Triapine® In Combination With Doxorubicin In Refractory Tumors
Trial Start Date		2004-03-05
Trial Completion Date		2008-07-28
Registered in ClinicalTrials.gov		NCT00079014
Date Submitted to PDQ		2004-01-16
Information Last Verified		2006-08-24
NCI Grant/Contract Number		CA14520, CA62491

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