Status:
COMPLETED
Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 respons...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00293280
Start Date
July 1 2005
Last Update
May 6 2013
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410