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3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gemcitabine hydrochloride
triapine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

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

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • University of Minnesota Cancer Center
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • University of Texas - MD Anderson Cancer Center
  • University Medical Center Nijmegen

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
November 5, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00064064
Brief Title
3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer
Official Title
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine. Determine the progression-free and overall survival in patients treated with this regimen. Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
triapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands

12. IPD Sharing Statement

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3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

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