3-AP as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma (Cancer) of the Pancreas - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00085371

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: 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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: triapine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone Ultrase

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival rates at 3- and 6-months [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Tolerability [ Designated as safety issue: Yes ]
Time to treatment failure [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Disease progression [ Designated as safety issue: No ]
Tumor response [ Designated as safety issue: No ]
Understanding of 3-AP and its effects on cellular processes as evaluated by laboratory studies [ Designated as safety issue: No ]

Study Start Date:

July 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085371

Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:

Kyle D. Holen, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Attia S, Kolesar J, Mahoney MR, Pitot HC, Laheru D, Heun J, Huang W, Eickhoff J, Erlichman C, Holen KD. A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas. Invest New Drugs. 2008 Aug;26(4):369-79. Epub 2008 Feb 16.

Study ID Numbers:	CDR0000368762, MAYO-MC0345, NCI-6293
Study First Received:	June 10, 2004
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00085371 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Pancreatic Neoplasms
Gastrointestinal Agents
Endocrine System Diseases
Pancrelipase
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010