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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: triapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: triapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (partial and complete response) as assessed by RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free and overall survival |  |  | 
| Safety and feasibility |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer