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

Primary Purpose

Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
triapine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acinar Cell Adenocarcinoma of the Pancreas

Eligibility Criteria

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

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 compounds 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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (triapene)

Arm Description

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.

Outcomes

Primary Outcome Measures

Survival in patients receiving triapine as first-line therapy
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
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.

Secondary Outcome Measures

Incidence of adverse events assessed using CTCAE version 3.0
Time to treatment failure
Overall survival
Time to disease progression
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

Full Information

First Posted
June 10, 2004
Last Updated
October 7, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085371
Brief Title
Triapine as First-Line or Second-Line Therapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
Official Title
A Phase II Study Of Triapine For Advanced Adenocarcinoma Of The Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent 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
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (triapene)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
triapine
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Survival in patients receiving triapine as first-line therapy
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.
Time Frame
6 months
Title
Survival in patients receiving triapine as second-line therapy
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events assessed using CTCAE version 3.0
Time Frame
Up to 3 years
Title
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
Title
Overall survival
Time Frame
Up to 3 years
Title
Time to disease progression
Description
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to documentation of disease progression, assessed up to 3 years
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 compounds 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Holen
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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