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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Bronchoalveolar Cell Lung Cancer

Stage IIIB Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer

Adenocarcinoma of the Lung

Non-small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer

Treatments

Drug: bortezomib

Study type

Interventional

Funder types

NIH

Identifiers

NCT00118144

NCI-2009-00113 (Registry Identifier)

N01CM62207 (U.S. NIH Grant/Contract)

N01CM62209 (U.S. NIH Grant/Contract)

N01CM62208 (U.S. NIH Grant/Contract)

PHII-57 (Other Identifier)

N01CM62201 (U.S. NIH Grant/Contract)

7003 (Other Identifier)

CDR0000433404

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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