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

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00293280

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: lomustine	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Lomustine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Disease stabilization [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Association between clinical outcome and immunohistochemical staining [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	July 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293280

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Julie Brahmer, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000452787, JHOC-J0336, WIRB-20031229, WCCC-CO-00501
Study First Received:	February 16, 2006
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00293280
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Lomustine
Recurrence
Carcinoma
Adenocarcinoma of lung

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009