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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118144
• Other study ID #: NCI-2009-00113
• Secondary ID: NCI-2009-00113CD
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2005
• Last updated: August 4, 2014
• Start date: June 2005
• Est. completion date: December 2010

Study information

• Verified date: April 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Lung
• Adenocarcinoma, Bronchiolo-Alveolar
• Bronchoalveolar Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Drug:
• bortezomib
Given IV

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 5 years	No
Secondary	Progression-free Survival	Progression Free Survival using the product-limit method of Kaplan and Meier	Up to 5 years	No
Secondary	Overall Survival	Overall Suvival using the product-limit method of Kaplan and Meier.	Up to 5 years	No