A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Mario Sznol, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vion Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000306462
NCT ID:
NCT00064064
Start Date:
January 2003
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Sarah Cannon Cancer Center at Centennial Medical Center | Nashville, Tennessee 37203 |
