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

Lung Cancer Clinical Trial

Official title:

Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293280
• Other study ID #: JHOC-J0336, CDR0000452787
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: May 3, 2013
• Start date: July 2005

Study information

• Verified date: May 2013
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• lomustine

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Toxicity			Yes
Secondary	Disease stabilization			No
Secondary	Time to disease progression			No
Secondary	Overall survival			No
Secondary	Association between clinical outcome and immunohistochemical staining			No