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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00118144
Enrollment
42
Registered
2005-07-11
Start date
2005-06-30
Completion date
2010-12-31
Last updated
2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGbortezomib

Given IV

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.Up to 5 yearsA 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

MeasureTime frameDescription
Progression-free SurvivalUp to 5 yearsProgression Free Survival using the product-limit method of Kaplan and Meier
Overall SurvivalUp to 5 yearsOverall Suvival using the product-limit method of Kaplan and Meier.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
42
Total42

Baseline characteristics

CharacteristicArm 1
Age, Continuous68 years
Region of Enrollment
United States
42 participants
Sex: Female, Male
Female
23 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
42 / 42
serious
Total, serious adverse events
12 / 42

Outcome results

Primary

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.

Time frame: Up to 5 years

ArmMeasureValue (NUMBER)
Arm 1Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.5 percentage of responders
Secondary

Overall Survival

Overall Suvival using the product-limit method of Kaplan and Meier.

Time frame: Up to 5 years

ArmMeasureValue (MEAN)
Arm 1Overall Survival13.6 Months
Secondary

Progression-free Survival

Progression Free Survival using the product-limit method of Kaplan and Meier

Time frame: Up to 5 years

ArmMeasureValue (MEDIAN)
Arm 1Progression-free Survival5.5 Months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026