Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Acinar Cell Adenocarcinoma of the Pancreas

Treatments: Drug: triapine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00085371

6293 (Other Identifier)

MC0345 (Other Identifier)

MAYO-MC0345

NCI-6293

NCI-2012-01452 (Registry Identifier)

CDR0000368762

N01CM62205 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This phase II trial is studying how well triapine works as first-line or second-line therapy in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the pancreas. Drugs used in chemotherapy, such as triapine, work in different ways to stop tumor cells from dividing so they stop growing or die.

Full description

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. Determine the toxicity and tolerability of this drug in these patients. II. Determine the time to treatment failure in patients treated with this drug. III. Determine overall survival and disease progression in patients treated with this drug.

IV. Determine tumor response in patients treated with this drug. V. Determine laboratory studies that will increase our understanding of Triapine and its effects on cellular processes.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).

Patients receive 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

• 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

• Performance status - ECOG 0-2

• At least 6 weeks

• Absolute neutrophil count >= 1,500/mm^3

• Platelet count >= 75,000/mm^3

• AST =< 3 times upper limit of normal (ULN)

• Bilirubin =< 1.5 times ULN

• Creatinine =< 1.5 times ULN

• Creatinine clearance > 60 mL/min

• No uncontrolled congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No pulmonary disease requiring oxygen

• 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

• No other concurrent antineoplastic therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational therapy for the malignancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Treatment (triapene)

Experimental group

Description:

Patients receive 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.

Treatment:

Drug: triapine