We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118144
First Posted: July 11, 2005
Last Update Posted: August 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition Intervention Phase
Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Drug: bortezomib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis. [ Time Frame: Up to 5 years ]
    A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to 5 years ]
    Progression Free Survival using the product-limit method of Kaplan and Meier

  • Overall Survival [ Time Frame: Up to 5 years ]
    Overall Suvival using the product-limit method of Kaplan and Meier.


Enrollment: 42
Study Start Date: June 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
Drug: bortezomib
Given IV

Detailed Description:

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this drug.

II. Determine the time to disease progression in patients treated with this drug.

III. 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • 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
  • Performance status:

    • ECOG 0-2
  • Life expectancy >3 months
  • 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
  • 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)
  • At least 4 weeks since prior corticosteroids
  • 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
  • No concurrent routine granulocyte colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • At least 2 weeks since prior radiotherapy
  • 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
  • Hematopoietic:

    • Absolute neutrophil count >= 1,500/mm3
    • Platelet count >= 100,000/mm3
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118144


Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Gandara City of Hope Medical Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118144     History of Changes
Other Study ID Numbers: NCI-2009-00113
NCI-2009-00113 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000433404
PHII-57 ( Other Identifier: City of Hope )
7003 ( Other Identifier: CTEP )
N01CM62208 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: August 4, 2014
Results First Posted: August 21, 2014
Last Update Posted: August 21, 2014
Last Verified: April 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bortezomib
Antineoplastic Agents


To Top