A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate (partial and complete response) as assessed by RECIST criteria
Safety Issue:
No
Principal Investigator
Mario Sznol, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vion Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000306461
NCT ID:
NCT00064051
Start Date:
January 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
| Indiana Oncology Hematology Consultants | Indianapolis, Indiana 46202 |
