Triapine As First-Line Or Second-Line Therapy In Treating Patients With Locally Advanced Or Metastatic Cancer Of The Pancreas

Study Overview

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

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.

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.

Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: triapine

NCI-2012-01452
NCI-2012-01452 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
MAYO-MC0345
CDR0000368762
NCI-6293
MC0345 (OTHER Identifier) (OTHER: Mayo Clinic)
6293 (OTHER Identifier) (OTHER: CTEP)
N01CM62205 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2004-06-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-10-07
First Submitted that Met QC Criteria 2004-06-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-10-08
First Posted (ESTIMATED) 2004-06-11	Results First Posted N/A	Last Verified 2013-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (triapene) 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.	DRUG: triapine Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (triapene)

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.

DRUG: triapine

Given IV

Primary Outcome Measures	Measure Description	Time Frame
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.	6 months
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.	4 months

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events assessed using CTCAE version 3.0		Up to 3 years
Time to treatment failure		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		Up to 3 years
Time to disease progression	The distribution of time to progression will be estimated using the method of Kaplan-Meier.	Time from registration to documentation of disease progression, assessed up to 3 years
Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart		6 months (first 6 courses of treatment)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kyle Holen, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record