3-AP as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma (Cancer)
of the Pancreas
This study is currently recruiting patients.
Sponsored by: |
Mayo Clinic Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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: Phase II trial to study the effectiveness of 3-AP as first-line or second-line therapy in treating patients who have
locally advanced or metastatic adenocarcinoma (cancer) of the pancreas.
Condition
|
Treatment or Intervention |
Phase |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer
|
Drug: 3-AP Procedure: chemotherapy
|
Phase II
|
MedlinePlus related topics: Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) as First- or Second-Line Therapy in Patients With Locally Advanced or Metastatic Adenocarcinoma
of the Pancreas
Further Study Details:
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
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
Chemotherapy
- See Disease Characteristics
Endocrine therapy
Radiotherapy
- See Disease Characteristics
Surgery
Other
- No other concurrent antineoplastic therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational therapy for the malignancy
Location
and Contact
Information
Arizona Mayo Clinic Scottsdale, Scottsdale,
Arizona,
85259,
United States; Recruiting
District of Columbia Howard University Cancer Center at Howard University Hospital, Washington,
District of Columbia,
20060,
United States; Recruiting
Maryland Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,
Maryland,
21231,
United States; Recruiting
Daniel A. Laheru, MD
410-955-8974
Michigan Barbara Ann Karmanos Cancer Institute, Detroit,
Michigan,
48201-1379,
United States; Recruiting
Patricia LoRusso, DO
313-993-0559
Minnesota Mayo Clinic Cancer Center, Rochester,
Minnesota,
55905,
United States; Recruiting
Missouri Siteman Cancer Center, Saint Louis,
Missouri,
63110,
United States; Recruiting
Paula M. Fracasso, MD, PhD
214-454-8817
Wisconsin University of Wisconsin Comprehensive Cancer Center, Madison,
Wisconsin,
53792-3236,
United States; Recruiting
Kyle Holen, MD
608-265-0051
Study chairs or principal investigators
Kyle Holen, MD, Study Chair, University of Wisconsin Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000368762; MAYO-MC0345; NCI-6293
Record last reviewed:
September 2004
Record first received:
June 10, 2004
ClinicalTrials.gov Identifier:
NCT00085371Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29