Know Cancer

forgot password

A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

Phase 2
18 Years
Not Enrolling
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

Thank you

Trial Information

A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas


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.


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

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.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival in patients receiving triapine as first-line therapy

Outcome Description:

The point estimate of the success rates will be calculated as the number of successes divided by the number of evaluable patients, with confidence intervals calculated by the method of Duffy and Santner.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Kyle Holen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell



Mayo Clinic Rochester, Minnesota  55905