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

Primary Purpose

Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
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
Progression Free Survival using the product-limit method of Kaplan and Meier
Overall Survival
Overall Suvival using the product-limit method of Kaplan and Meier.

Full Information

First Posted
July 8, 2005
Last Updated
August 4, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00118144
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Progression Free Survival using the product-limit method of Kaplan and Meier
Time Frame
Up to 5 years
Title
Overall Survival
Description
Overall Suvival using the product-limit method of Kaplan and Meier.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gandara
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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