3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
This study has been suspended.
Sponsored by: |
Vion Pharmaceuticals |
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have unresectable
or metastaticpancreatic cancer.
Condition
|
Treatment or Intervention |
Phase |
stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer recurrent pancreatic cancer
|
Drug: 3-AP Drug: gemcitabine Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: enzyme inhibitor therapy
|
Phase II
|
MedlinePlus related topics: Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine in Patients With Unresectable or Metastatic Pancreatic Cancer
Further Study Details:
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.
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.
PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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 less 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 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
Radiotherapy
- See Disease Characteristics
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
Location
Information
Illinois University of Chicago Cancer Research Center, Chicago,
Illinois,
60637-1470,
United States
Indiana Indiana Oncology Hematology Consultants, Indianapolis,
Indiana,
46202,
United States
Minnesota University of Minnesota Cancer Center, Minneapolis,
Minnesota,
55455,
United States
Tennessee Sarah Cannon Cancer Center at Centennial Medical Center, Nashville,
Tennessee,
37203,
United States
Belgium Universitair Ziekenhuis Gent, Ghent,
B-9000,
Belgium
Netherlands Maasland Hospital, Sittard,
6131 BK,
Netherlands
United Kingdom, England Christie Hospital N.H.S. Trust, Manchester,
England,
M20 4BX,
United Kingdom
Royal Marsden Hospital - Sutton, Sutton,
England,
SM2 5PT,
United Kingdom
Study chairs or principal investigators
Mario Sznol, MD, Study Chair, Vion Pharmaceuticals
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000306461; VION-CLI-031
Record last reviewed:
August 2004
Record first received:
July 8, 2003
ClinicalTrials.gov Identifier:
NCT00064051Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22