Lung Cancer
Conditions
Keywords
recurrent small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer
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 II trial is studying how well VNP40101M works in treating patients with recurrent or refractory locally advanced or metastatic small cell lung cancer.
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. * Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease state (sensitive relapse \[progressive disease \> 3 months after responding to first-line chemotherapy\] vs resistant disease \[progressive disease during or ≤ 3 months after first-line chemotherapy\]). Patients receive VNP40101M IV over 15-30 minutes once weekly for 3 weeks. Treatment repeats every 6 weeks for up to 6 courses. Patients achieving a complete response (CR) receive 2 additional courses of therapy after CR. After completion of study treatment, patients are followed periodically for up to 18 months. PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study.
Interventions
DRUGlaromustine
Sponsors
Vion Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete and partial response) | — |
| Toxicity | — |
Countries
United States
Outcome results
None listed