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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Survival in patients receiving triapine as first-line therapy [ Time Frame: 6 months ]
    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.
  • Survival in patients receiving triapine as second-line therapy [ Time Frame: 4 months ]
    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.


Original Primary Outcome:

Current Secondary Outcome:

  • Incidence of adverse events assessed using CTCAE version 3.0 [ Time Frame: Up to 3 years ]
  • Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years ]
  • Overall survival [ Time Frame: Up to 3 years ]
  • Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 3 years ]
    The distribution of time to progression will be estimated using the method of Kaplan-Meier.
  • Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: 6 months (first 6 courses of treatment) ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: June 10, 2004
Date Started: July 2004
Date Completion:
Last Updated: October 7, 2013
Last Verified: October 2013