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

• Status: Completed
• Trial end date: 2009-01-07
• Target enrollment: 0
• Participant gender: All

Summary

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: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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