RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 3-AP as first-line or second-line therapy in treating patients who have locally advanced or metastatic adenocarcinoma (cancer) of the pancreas.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the pancreas recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: 3-AP  Procedure: chemotherapy	Phase II

OBJECTIVES: Primary

• Determine the 3- and 6-month survival rate of patients with locally advanced or metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or second-line therapy.

Secondary

• Determine the toxicity and tolerability of this drug in these patients.
• Determine the time to treatment failure in patients treated with this drug.
• Determine overall survival and disease progression in patients treated with this drug.
• Determine tumor response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).

Patients receive 3-AP (Triapene®) IV over 2 hours on days 1-4 and 15-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3-6 months for 3 years.

PROJECTED ACCRUAL: A total 48-116 patients (24-58 per stratum) will be accrued for this study within 1-1.5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Unresectable disease
• Locally advanced or metastatic disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Measurable lesions outside prior radiotherapy* field OR measurable lesions actively growing in the site of prior radiotherapy* NOTE: *For patients who received prior radiotherapy
• No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing regimen for metastatic, unresectable, or locally advanced pancreatic cancer
• Adjuvant therapy not considered prior chemotherapy if all treatment was completed > 6 months before tumor recurrence
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3

Hepatic

• AST ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance > 60 mL/min

Cardiovascular

• No uncontrolled congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Pulmonary

• No pulmonary disease requiring oxygen

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)
• No active or ongoing infection
• No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related compounds
• No concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• No other concurrent antineoplastic therapy
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational therapy for the malignancy

Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States; Recruiting
District of Columbia
      Howard University Cancer Center at Howard University Hospital, Washington,  District of Columbia,  20060,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
Missouri
      Siteman Cancer Center, Saint Louis,  Missouri,  63110,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-3236,  United States; Recruiting

Study chairs or principal investigators

Kyle Holen, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000368762; MAYO-MC0345; NCI-6293
Record last reviewed:  September 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085371
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22