3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: gemcitabine hydrochloride; Drug: triapine

• Registration Number: NCT00078975
• Lead Sponsor: University Health Network, Toronto

Brief Summary

RATIONALE: 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. 3-AP may help gemcitabine kill more tumor cells by making them more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with recurrent, unresectable, or metastatic pancreatic cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the antitumor activity of 3-AP (Triapine®) and gemcitabine, in terms of complete and partial response and 6-month progression-free disease, in patients with recurrent, unresectable, or metastatic pancreatic cancer.

Secondary

* Determine the objective response rates, median survival, 1-year survival rate, duration of response or stable disease, and progression-free survival of patients treated with this regimen.

* Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-AP (Triapine®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 2 courses of therapy beyond response.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 28-50 patients will be accrued for this study within 7-13 months.

Study Timeline

• Study First Submitted: 2004-03-08
• Study First Submitted QC: 2004-03-08
• Study First Posted: 2004-03-09
• Study Start: 2004-04
• Primary Completion: 2005-12
• Study Completion: 2009-01-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triapine in combination with Gemcitabine	gemcitabine hydrochloride	-
Triapine in combination with Gemcitabine	triapine	-

Primary Outcome Measures

Name	Time	Method
Objective response (complete and partial)	Every 8 weeks for the duration of the trial, an expected average of 5 years
Prolonged stable disease rate	Stable disease of 6 or more months

Secondary Outcome Measures

Name	Time	Method
Median survival	For duration of trial, an expected average of 5 years
Survival rate at 1 year	1 year
Response duration	From date of response until progression
Progression-free survival	From date of response until progression or death
Safety and tolerability	Up to 1 year

Trial Locations

Locations (4)

Margaret and Charles Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus; 🇨🇦 Ottawa, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada