3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer
This study is currently recruiting patients.
Sponsored by: |
Vion Pharmaceuticals |
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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.
Condition
|
Treatment or Intervention |
Phase |
recurrent non-small cell lung cancer stage IV non-small cell lung cancer
|
Drug: 3-AP Drug: gemcitabine Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: enzyme inhibitor therapy
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer
Further Study Details:
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.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
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
Location
and Contact
Information
Illinois University of Chicago Cancer Research Center, Chicago,
Illinois,
60637-1470,
United States; Recruiting
Patrick C. Ma, MD, MSC
773-702-6304
Minnesota University of Minnesota Cancer Center, Minneapolis,
Minnesota,
55455,
United States; Recruiting
Arkadiusz Dudek, MD
612-624-0123
Tennessee Sarah Cannon Cancer Center at Centennial Medical Center, Nashville,
Tennessee,
37203,
United States; Recruiting
Texas University of Texas - MD Anderson Cancer Center, Houston,
Texas,
77030-4009,
United States; Recruiting
George R. Blumenschein, MD
713-792-6363
Netherlands University Medical Center Nijmegen, Nijmegen,
NL-6500 HB,
Netherlands; Recruiting
Study chairs or principal investigators
Mario Sznol, MD, Study Chair, Vion Pharmaceuticals
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000306462; VION-CLI-030; MDA-ID-030143
Record last reviewed:
June 2003
Record first received:
July 8, 2003
ClinicalTrials.gov Identifier:
NCT00064064Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22