Pancreatic Cancer
Conditions
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
Brief summary
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.
Detailed 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.
Interventions
DRUGgemcitabine hydrochloride
DRUGtriapine
Sponsors
Vion Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 PRIOR CONCURRENT THERAPY: Biologic therapy * Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed Chemotherapy * No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * More than 3 weeks since prior surgery and recovered Other * More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease * No other concurrent investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (partial and complete response) as assessed by RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free and overall survival | — |
| Safety and feasibility | — |
Countries
Belgium, United Kingdom, United States
Outcome results
None listed