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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00293280
First received: February 16, 2006
Last updated: May 3, 2013
Last verified: May 2013
  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 2

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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

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
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Julie Brahmer, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00293280     History of Changes
Other Study ID Numbers: JHOC-J0336, CDR0000452787, P30CA006973, JHOC-J0336, WIRB-20031229, WCCC-CO-00501
Study First Received: February 16, 2006
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lomustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014