NCT00064064

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: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung 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 lung-cancer

Geographic Reach
2 countries

5 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
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 6, 2013

Status Verified

August 1, 2004

First QC Date

July 8, 2003

Last Update Submit

November 5, 2013

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

gemcitabine hydrochlorideDRUG
triapineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Metastatic disease * Progressive disease after no more than 2 prior cytotoxic regimens containing at least 1 of the following drugs: * Cisplatin * Carboplatin * Taxane * Vinorelbine * Measurable disease * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 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 * ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) * 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 cardiac arrhythmias Pulmonary * No dyspnea at rest * No supplemental oxygen dependence Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * No other prior or concurrent malignancy except carcinoma in situ of the cervix previously treated by cone biopsy and/or resection, nonmetastatic basal cell or squamous cell skin cancer, or any stage I malignancy curatively resected more than 5 years ago * No other concurrent life-threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy * Prior non-cytotoxic biologic regimens allowed (e.g., vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors) Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No prior gemcitabine * No prior 3-AP Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * More than 3 weeks since prior surgery and recovered Other * More than 3 weeks since prior non-cytotoxic regimens

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

Sponsors & Collaborators

Study Sites (5)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, 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

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

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

Study Completion

August 1, 2008

Last Updated

November 6, 2013

Record last verified: 2004-08

Locations

US(4)NL(1)