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

Phase 2
18 Years
Open (Enrolling)
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

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Trial Information

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


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.


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.

Inclusion 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate with bortezomib evaluated by both RECIST criteria and computer-assisted image analysis.

Outcome 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 rates will be separately summarized and the planned phase II decision rules will be separately applied to the two strata. Fisher's exact test comparing strata will be calculated, recognizing that this test has limited power with phase II sample sizes. A bivariate 95% confidence region will be calculated for the response rate in the two strata, as a means of jointly evaluating the strata.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

David Gandara

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



City of Hope Medical Center Duarte, California  91010