Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry VION-CLI-031 NCT00064051

Objectives

1. Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.
2. Determine the progression-free interval and survival of patients treated with this regimen.
3. Determine the safety and feasibility of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed pancreatic cancer
  • Unresectable or metastatic disease



• Measurable disease
  • Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy



• No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed

Chemotherapy

• No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery

• More than 3 weeks since prior surgery and recovered

Other

• More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
• No other concurrent investigational drugs

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
• Chronic viral hepatitis allowed

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months
• No uncontrolled congestive heart failure
• No uncontrolled coronary artery disease
• No uncontrolled arrhythmias

Pulmonary

• No dyspnea at rest
• No dependence on supplemental oxygen

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No other malignancy except any of the following:
  • Carcinoma in situ of the cervix treated with cone biopsy or resection
  • Nonmetastatic basal cell or squamous cell skin cancer
  • Any stage I malignancy curatively resected more than 5 years ago
• No active infection
• No known or suspected glucose-6-phosphate dehydrogenase deficiency
• No other concurrent life threatening illness

Expected Enrollment

A total of 50-95 patients will be accrued for this study within 18-24 months.

Outcomes

Objective response rate (partial and complete response) as assessed by RECIST criteria

Progression-free and overall survival
Safety and feasibility

Outline

This is a multicenter study.

• Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.



• Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.

Trial Contact Information

Trial Lead Organizations

Vion Pharmaceuticals, Incorporated

Mario Sznol, MD, Protocol chair		Ph: 203-498-4210

Registry Information
Official Title		A Phase II Study of Triapine in Combination with Gemcitabine in Patients with Pancreatic Cancer
Trial Start Date		2003-01-03
Trial Completion Date		2006-08-25
Registered in ClinicalTrials.gov		NCT00064051
Date Submitted to PDQ		2003-05-15
Information Last Verified		2008-08-22

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