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

NCT ID: NCT00064064

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2008-08-31

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

triapine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mario Sznol, MD

Role: STUDY_CHAIR

Vion Pharmaceuticals

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

University Medical Center Nijmegen

Nijmegen, , Netherlands

Countries

United States; Netherlands

Other Identifiers

VION-CLI-030

Identifier Type: -

Identifier Source: secondary_id

MDA-ID-030143

Identifier Type: -

Identifier Source: secondary_id

CDR0000306462

Identifier Type: -

Identifier Source: org_study_id