Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MAYO-MC0345 6293, NCI-6293, NCT00085371

Objectives

Primary

1. 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

1. Determine the toxicity and tolerability of this drug in these patients.
2. Determine the time to treatment failure in patients treated with this drug.
3. Determine overall survival and disease progression in patients treated with this drug.
4. Determine tumor response in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³

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

Expected Enrollment

A total 48-116 patients (24-58 per stratum) will be accrued for this study within 1-1.5 years.

Outcomes

Survival rates at 3- and 6-months

Toxicity
Tolerability
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

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.

Attia S, Kolesar J, Mahoney MR, et al.: A phase 2 consortium (P2C) trial of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) for advanced adenocarcinoma of the pancreas. Invest New Drugs 26 (4): 369-79, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Kyle Holen, MD, Protocol chair		Ph: 608-265-0051; 800-622-8922

Registry Information
Official Title		A Phase II Study Of Triapine® For Advanced Adenocarcinoma Of The Pancreas
Trial Start Date		2004-07-16
Registered in ClinicalTrials.gov		NCT00085371
Date Submitted to PDQ		2004-04-28
Information Last Verified		2005-12-13
NCI Grant/Contract Number		N01-CM17104, P30-CA15083

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