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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

lomustineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes: * Squamous cell * Adenocarcinoma * Adenosquamous * Large cell anaplastic * Bronchoalveolar * Non-small cell carcinoma not otherwise specified (NOS) * Stage IIIB disease (with a pleural effusion) or stage IV disease * Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy * 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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Response rate

Secondary Outcomes

Toxicity

Disease stabilization

Time to disease progression

Overall survival

Association between clinical outcome and immunohistochemical staining

Data from ClinicalTrials.gov

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