Clinical Trial: 3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Trial Of Gemcitabine And Triapine In Refractory Metastatic Breast Cancer

Brief Summary: Phase II trial to study the effectiveness of combining 3-AP with gemcitabine in treating patients who have refractory metastatic breast cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining 3-AP with gemcitabine may kill more tumor cells

Detailed Summary:

OBJECTIVES: Primary I. Determine antitumor activity of 3-AP (Triapine®) and gemcitabine by measuring tumor size in patients with refractory metastatic breast cancer.

Secondary I. Determine the safety and tolerability of this regimen in these patients. II. Determine the time to disease progression in patients treated with this regimen.

III. Determine the effect of multidrug resistance polymorphisms on pharmacokinetics and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine®) IV over 2 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.

PROJECTED ACCRUAL: A total of 30-75 patients will be accrued for this study within 24 months.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Confirmed response (complete or partial response) [ Time Frame: Up to 6 months ]

Ninety five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.


Original Primary Outcome:

Current Secondary Outcome:

  • Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 3.0 [ Time Frame: Up to 3 years ]
  • Time to progression [ Time Frame: Time from registration to the time of progression, assessed up to 3 years ]
    The distribution of time to progression will be estimated using the method of Kaplan-Meier.
  • Overall survival [ Time Frame: Time from registration to death due to any cause, assessed up to 3 years ]
    The distribution of overall survival will be estimated using the method of Kaplan-Meier.
  • Changes in tyrosyl radical and cell-cycle arrest on buccal mucosa [ Time Frame: Pre-infusion, 2 and 4.5 hours post-infusion ]
  • Changes in R2 messenger ribonucleic acid (mRNA) on protein levels before and after treatment with triapine [ Time Frame: Pre-infusion, 2 and 4.5 hours post-infusion ]
  • MDR polymorphism on tumor tissue [ Time Frame: Baseline ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 9, 2004
Date Started: October 2004
Date Completion:
Last Updated: January 15, 2013
Last Verified: January 2013