Status:
COMPLETED
VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung Cancer
Lead Sponsor:
Vion Pharmaceuticals
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase ...
Detailed Description
OBJECTIVES: * Determine the overall response rate (partial and complete) in patients with relapsed or refractory locally advanced or metastatic small cell lung cancer treated with VNP40101M. * Determ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically confirmed small cell lung cancer
- Locally advanced or metastatic disease
- Recurrent or progressive disease after first-line standard cytotoxic therapy
- Measurable or evaluable disease
- Brain metastasis allowed
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 2 months
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.5 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active uncontrolled bleeding
- No active infection
- Must not require supplemental oxygen at rest
- No active heart disease
- No myocardial infarction within the past 3 months
- No uncontrolled congestive heart failure
- No uncontrolled arrhythmias
- No uncontrolled coronary artery disease
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy, biologic therapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- Prior radiotherapy within the past 3 weeks allowed if exposure involves no more than 30% of bones with significant bone marrow-producing capabilities (e.g., vertebral bodies and long bones)
- At least 2 weeks since prior surgery or hormonal therapy
- Must not require any immediate palliative treatment including surgery
- Must have recovered from prior anticancer therapy
- Persistent, stable chronic toxic effects ≤ grade 1 are allowed
- No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
- No other concurrent anticancer therapy
- No other concurrent investigational agent
- No concurrent disulfiram
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00282022
Start Date
September 1 2005
Last Update
November 6 2013
Active Locations (9)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
3
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, United States, 06516
4
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, United States, 19713