Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as lomustine, 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 lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene.
* Determine whether the response rate in these patients is significantly greater than that of the historical control.

Secondary

* Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival.

Tertiary

* Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene.

OUTLINE: This is a multicenter study.

Patients receive oral lomustine once on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Conditions

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Lung Cancer

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lomustine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction
* Bidimensionally measurable or evaluable disease

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* No other active malignancies
* WBC ≥ 4,000/mm\^3 OR absolute neutrophil count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin normal
* AST \< 5 times upper limit of normal
* Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* No uncontrolled serious active infection
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 3 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens
* No prior therapy with nitrosoureas
* Recovered from prior radiation therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No