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

NCT ID: NCT00118144

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Given IV

Interventions

bortezomib

Given IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gandara

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2009-00113

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000433404

Identifier Type: -

Identifier Source: secondary_id

PHII-57

Identifier Type: OTHER

Identifier Source: secondary_id

7003

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62208

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62209

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62207

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00113

Identifier Type: -

Identifier Source: org_study_id