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Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118144
  Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: bortezomib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Bortezomib (PS-341) For Patients With Advanced Bronchiolo-Aveolar Carcinoma (BAC) or Adencarcinoma With BAC Features

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

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Overexpression of NF-kB, BCL-2, BCL-xL, and loss of p27 [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: June 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.

Secondary

  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the time to disease progression in patients treated with this drug.
  • Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).

Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 8-24 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features

    • Stage IIIB or IV disease

      • Patients with stage IIIB disease must be ineligible for definitive combined modality treatment with radiotherapy and chemotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Previously irradiated lesions are considered measurable only if lesion progressed after completion of radiotherapy
  • No unstable brain metastases

    • Brain metastases that are stable for ≥ 1 month after completion of prior radiotherapy, stereotactic surgery, or surgery are allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmias

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and for 30 days after completion of study treatment
  • No ongoing or active infection
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission
  • No peripheral neuropathy ≥ grade 2
  • No known hypersensitivity to bortezomib, boron, or mannitol
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent routine granulocyte colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

  • No more than 1 prior chemotherapy regimen for advanced BAC

    • Prior gefitinib or other known epidermal growth factor receptor (EGFR) inhibitors are not considered a systemic chemotherapy regimen
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • At least 4 weeks since prior corticosteroids

Radiotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Recovered from prior therapy (alopecia allowed)
  • At least 2 weeks since prior EGFR inhibitors
  • At least 4 weeks since prior anticonvulsants
  • No prior bortezomib
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Concurrent bisphosphonates for bone metastases allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118144

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553
Contact: Sharon Hiner, MD     925-370-5114     shiner@hsd.co.contra-costa.ca.us    
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Barbara J. Gitlitz, MD     323-865-3959        
Veterans Affairs Outpatient Clinic - Martinez Recruiting
Martinez, California, United States, 94553
Contact: Ted Wun, MD     925-372-2062        
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Everett E. Vokes, MD     773-702-9306     evokes@medicine.bsd.uchicago.edu    
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Patricia M. LoRusso, DO     313-745-8860        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center     614-293-4976     osu@emergingmed.com    
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton     717-531-3779     CTO@hmc.psu.edu    
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: David R. Gandara, MD University of California, Davis
Investigator: Suresh Ramalingam, MD UPMC Cancer Centers
  More Information

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

Study ID Numbers: CDR0000433404, CCC-PHII-57, NCI-7003, UPCI-04163
Study First Received: July 8, 2005
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00118144  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
bronchoalveolar cell lung cancer
adenocarcinoma of the lung

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Lung Diseases
Bortezomib
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Recurrence
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009