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

Brief Title

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

Official Title

Phase II Study of Bortezomib (PS-341) for Patients With Advanced Bronchiolo-Alveolar Carcinoma (BAC) or Adenocarcinoma With BAC Features

Brief Summary

      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.
    

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.

Secondary Outcome

 Progression-free Survival

Condition

Adenocarcinoma of the Lung

Intervention

bortezomib

Study Arms / Comparison Groups

 Arm I

Description:  Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

42

Start Date

June 2005

Completion Date

December 2010

Primary Completion Date

December 2010

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Gandara, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00118144

Organization ID

NCI-2009-00113

Secondary IDs

NCI-2009-00113

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Study Sponsor

David Gandara, Principal Investigator, City of Hope Medical Center

Verification Date

April 2013