RATIONALE: Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have recurrent, unresectable, or metastatic pancreatic cancer.

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  Drug: gemcitabine  Procedure: chemosensitization/potentiation  Procedure: chemotherapy	Phase II

OBJECTIVES: Primary

• Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent, unresectable, or metastatic pancreatic cancer.

Secondary

• Determine the objective response rates, median survival, 1-year survival rate, duration of response or stable disease, and progression-free survival of patients treated with this regimen.
• Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13 months.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic adenocarcinoma
• Recurrent, unresectable, or metastatic disease
• At least 1 unidimensionally measurable lesion
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• Prior radiation field must not have encompassed the only site of measurable disease
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• No G6PD deficiency

Hepatic

• Bilirubin ≤ 1.5 times normal
• AST and ALT ≤ 2.5 times upper limit of normal

Renal

• Creatinine ≤ 1.5 times normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

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

Pulmonary

• No severe pulmonary disease
• No dyspnea at rest
• No dependence on supplemental oxygen use

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study treatment
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No other concurrent uncontrolled illness that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy
• More than 4 weeks since prior adjuvant fluorouracil therapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• See Chemotherapy
• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

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

Canada, Ontario
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
      Ottawa Regional Cancer Centre, Ottawa,  Ontario,  K1H 1C4,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting

Study chairs or principal investigators

David Saltman, MD, PhD,  Principal Investigator,  Margaret and Charles Juravinski Cancer Centre   

Study ID Numbers:  CDR0000353205; PMH-PHL-023; NCI-6271
Record last reviewed:  August 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00078975
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22