Clinical trial NCT00118144: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-07-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis.
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
Study officials:
affiliation: City of Hope Medical Center
name: David Gandara
role: PRINCIPAL_INVESTIGATOR
References: