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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118144
First received: July 8, 2005
Last updated: August 4, 2014
Last verified: April 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Progression Free Survival using the product-limit method of Kaplan and Meier

  • Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00118144

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
Investigators
Principal Investigator: David Gandara Beckman Research Institute
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118144     History of Changes
Other Study ID Numbers: NCI-2009-00113, NCI-2009-00113, CDR0000433404, PHII-57, 7003, N01CM62208, N01CM62201, N01CM62209, N01CM62207
Study First Received: July 8, 2005
Results First Received: August 4, 2014
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014