3-AP as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma (Cancer) of the Pancreas
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: triapine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Kyle D. Holen, MD, Study Chair, Affiliation: University of Wisconsin, Madison
Summary
RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well 3-AP works as first-line or second-line
therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of
the pancreas.
Clinical Details
Official title: A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
Study design: Treatment, Open Label
Primary outcome: Survival rates at 3- and 6-months
Secondary outcome: ToxicityTolerability Time to treatment failure Overall survival Disease progression Tumor response Understanding of 3-AP and its effects on cellular processes as evaluated by laboratory studies
Detailed description:
OBJECTIVES:
Primary
- Determine the 3- and 6-month survival rate of patients with locally advanced or
metastatic adenocarcinoma of the pancreas treated with 3-AP (Triapine^®) as first- or
second-line therapy.
Secondary
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the time to treatment failure in patients treated with this drug.
- Determine overall survival and disease progression in patients treated with this drug.
- Determine tumor response in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy
(yes vs no).
Patients receive 3-AP (Triapene®) IV over 2 hours on days 1-4 and 15-18. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months for 3 years.
PROJECTED ACCRUAL: A total 48-116 patients (24-58 per stratum) will be accrued for this study
within 1-1. 5 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Unresectable disease
- Locally advanced or metastatic disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥
10 mm by spiral CT scan
- Measurable lesions outside prior radiotherapy* field OR measurable lesions
actively growing in the site of prior radiotherapy* NOTE: *For patients who
received prior radiotherapy
- No prior chemotherapy OR previously treated with 1, and only 1, gemcitabine-containing
regimen for metastatic, unresectable, or locally advanced pancreatic cancer
- Adjuvant therapy not considered prior chemotherapy if all treatment was completed
> 6 months before tumor recurrence
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 6 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 1. 5 times ULN
Renal
- Creatinine ≤ 1. 5 times ULN OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- No uncontrolled congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary
- No pulmonary disease requiring oxygen
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African,
Asian, or Mediterranean origin or ancestry)
- No active or ongoing infection
- No hypersensitivity or severe allergic reaction to 3-AP (Triapine®) or related
compounds
- No concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No other concurrent antineoplastic therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational therapy for the malignancy
Locations and Contacts
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
Howard University Cancer Center at Howard University Hospital, Washington, District of Columbia 20060, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2004
Last updated: May 23, 2008
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