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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
gemcitabine hydrochloride
triapine
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Recurrent, unresectable, or metastatic disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Prior radiation field must not have encompassed the only site of measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No G6PD deficiency Hepatic Bilirubin ≤ 1.5 times normal AST and ALT ≤ 2.5 times upper limit of normal Renal Creatinine ≤ 1.5 times normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No unstable angina pectoris No cardiac arrhythmia No symptomatic congestive heart failure Pulmonary No severe pulmonary disease No dyspnea at rest No dependence on supplemental oxygen use Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy More than 4 weeks since prior adjuvant fluorouracil therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics See Chemotherapy More than 4 weeks since prior radiotherapy and recovered Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer therapy No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • Margaret and Charles Juravinski Cancer Centre
  • London Regional Cancer Program at London Health Sciences Centre
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triapine in combination with Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Objective response (complete and partial)
Prolonged stable disease rate

Secondary Outcome Measures

Median survival
Survival rate at 1 year
Response duration
Progression-free survival
Safety and tolerability

Full Information

First Posted
March 8, 2004
Last Updated
September 13, 2018
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00078975
Brief Title
3-AP and Gemcitabine in Treating Patients With Recurrent, Unresectable, or Metastatic Pancreatic Cancer
Official Title
A Phase II Study of Triapine in Combination With Gemcitabine in Recurrent/Unresectable/Metastatic Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
January 7, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triapine in combination with Gemcitabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
triapine
Primary Outcome Measure Information:
Title
Objective response (complete and partial)
Time Frame
Every 8 weeks for the duration of the trial, an expected average of 5 years
Title
Prolonged stable disease rate
Time Frame
Stable disease of 6 or more months
Secondary Outcome Measure Information:
Title
Median survival
Time Frame
For duration of trial, an expected average of 5 years
Title
Survival rate at 1 year
Time Frame
1 year
Title
Response duration
Time Frame
From date of response until progression
Title
Progression-free survival
Time Frame
From date of response until progression or death
Title
Safety and tolerability
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic adenocarcinoma Recurrent, unresectable, or metastatic disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Prior radiation field must not have encompassed the only site of measurable disease No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No G6PD deficiency Hepatic Bilirubin ≤ 1.5 times normal AST and ALT ≤ 2.5 times upper limit of normal Renal Creatinine ≤ 1.5 times normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No unstable angina pectoris No cardiac arrhythmia No symptomatic congestive heart failure Pulmonary No severe pulmonary disease No dyspnea at rest No dependence on supplemental oxygen use Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy except fluorouracil given as adjuvant therapy OR as a radiosensitizer during radiotherapy More than 4 weeks since prior adjuvant fluorouracil therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics See Chemotherapy More than 4 weeks since prior radiotherapy and recovered Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer therapy No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm J. Moore, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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