Overview

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