Clinical trial NCT00293280: Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official title: Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-02-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Toxicity
measure: Disease stabilization
measure: Time to disease progression
measure: Overall survival
measure: Association between clinical outcome and immunohistochemical staining
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Julie Brahmer, MD
role: STUDY_CHAIR
References: