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

Vion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: triapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00064051

VION-CLI-031

CDR0000306461 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug.

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

Full description

OBJECTIVES:

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

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.

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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/mm^3
Platelet count at least 100,000/mm^3
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