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

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: lomustine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00293280

JHOC-J0336, CDR0000452787

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-J0336

WCCC-CO-00501

WIRB-20031229

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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