3-AP And Gemcitabine In Treating Patients With Unresectable Or Metastatic Pancreatic Cancer

Study Overview

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

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.

OBJECTIVES: * Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine. * Determine the progression-free interval and survival of patients treated with this regimen. * Determine the safety and feasibility of this regimen in these patients. OUTLINE: This is a multicenter study. * Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. * Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months. PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: triapine

VION-CLI-031
CDR0000306461 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

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 2003-07-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-08-01
First Submitted that Met QC Criteria 2003-07-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-08-02
First Posted (ESTIMATED) 2003-07-09	Results First Posted N/A	Last Verified 2008-08

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:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Objective response rate (partial and complete response) as assessed by RECIST criteria

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free and overall survival
Safety and feasibility

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 pancreatic cancer

Unresectable or metastatic disease
Measurable disease

Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
No CNS metastases

18 and over

ECOG 0-2

More than 3 months

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL (transfusion allowed)

Bilirubin no greater than 2.0 mg/dL
AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
Chronic viral hepatitis allowed

Creatinine no greater than 2.0 mg/dL

No myocardial infarction within the past 3 months
No uncontrolled congestive heart failure
No uncontrolled coronary artery disease
No uncontrolled arrhythmias

No dyspnea at rest
No dependence on supplemental oxygen

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
No other malignancy except any of the following:

Carcinoma in situ of the cervix treated with cone biopsy or resection
Nonmetastatic basal cell or squamous cell skin cancer
Any stage I malignancy curatively resected more than 5 years ago
No active infection
No known or suspected glucose-6-phosphate dehydrogenase deficiency
No other concurrent life threatening illness

Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed

No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer

Not specified

See Disease Characteristics
More than 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

More than 3 weeks since prior surgery and recovered

More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
No other concurrent investigational drugs

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Mario Sznol, MD, Vion Pharmaceuticals

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

Learn

Resources

PatientS

Caregivers

Clinical Trial Record