NCT00064051

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2003

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2008

Enrollment Period

3.6 years

First QC Date

July 8, 2003

Last Update Submit

August 1, 2013

Conditions

Pancreatic Cancer

Keywords

stage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (partial and complete response) as assessed by RECIST criteria

Secondary Outcomes (2)

  • Progression-free and overall survival

  • Safety and feasibility

Interventions

gemcitabine hydrochlorideDRUG
triapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * 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) Hepatic * 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 Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No myocardial infarction within the past 3 months * No uncontrolled congestive heart failure * No uncontrolled coronary artery disease * No uncontrolled arrhythmias Pulmonary * No dyspnea at rest * No dependence on supplemental oxygen Other * 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 CONCURRENT THERAPY: Biologic therapy * Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed Chemotherapy * No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * More than 3 weeks since prior surgery and recovered Other * More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana Oncology Hematology Consultants

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mario Sznol, MD

    Vion Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

January 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2008

Last Updated

August 2, 2013

Record last verified: 2008-08

Locations

GB(2)US(4)BE(1)