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

Learn more about:
Related Clinical Trial
Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer Adherence to Survivorship Care Guidelines in Health Care Providers for Non-Small Cell Lung Cancer and Colorectal Cancer Survivor Care Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Icotinib for Completed Resected IB NSCLC With EGFR Mutation Circulating Tumor DNA in Patients at High Risk for Lung Cancer Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers Radiation Therapy, Chemotherapy, and Soy Isoflavones in Treating Patients With Stage IIIA-IIIB Non-Small Cell Lung Cancer Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer S0536: Cetuximab, Paclitaxel, Carboplatin, and Bevacizumab in Treating Patients With Advanced Non-Small Cell Lung Cancer Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery Bevacizumab, Paclitaxel, Carboplatin, and Radiation Therapy to the Chest in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery QUILT-3.017: Study of NEO-201 in Solid Tumors Photodynamic Therapy in Treating Patients With Lung Cancer Vaccine Treatment for Advanced Non-Small Cell Lung Cancer S1300: Pemetrexed Disodium With or Without Crizotinib in Treating Patients With Stage IV Non-Small Cell Lung Cancer That Has Progressed After Crizotinib Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China ALK/ROS1/MET Mutations on Plasma ctDNA in Patients With NSCLC The Tracking Molecular Evolution for NSCLC (T-MENC) Study Phase 1a/1b Study of TPST-1495 Alone and With Pembrolizumab in Subjects With Solid Tumors An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer LMB-100 Followed by Pembrolizumab in the Treatment of Adults With Mesothelin-Expressing Non-Squamous Non-Small Cell Lung Cancer (NSCLC) P2 of RMT in Combo w Durvalumab or Durva + Chemo in Untreated Adenocarcinoma NSCLC Feasibility and Safety of Nintedanib in Combination With Nivolumab in Pretreated Patients With Advanced or Metastatic NSCLC of Adenocarcinoma Histology Targeted Stem Cells Expressing TRAIL as a Therapy for Lung Cancer Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC To Compare Efficacy and Safety of CT-P16 and EU-Approved Avastin as First-Line Treatment for Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer Hsp90 Inhibitor AUY922 and Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced NSCLC Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001) Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung Study of AXL1717 Compared to Docetaxel to Treat Squamous Cell Carcinoma or Adenocarcinoma of the Lung Lung Cancer Mutation Consortium Protocol The Detection of EGFR Mutations in Liquid Based Cytology Samples NOV120101 (Poziotinib) for 1st Line Monotherapy in Patients With Lung Adenocarcinoma A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03) Endostar Durative Transfusion Combined With Chemotherapy in the Treatment of Advanced Lung Adenocarcinoma The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR Telomere Biology in Early Adenocarcinoma of the Lung

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 Information


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

Administrative Informations


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