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

NCT00118144 | Completed Phase 2 Results

• 8 other identifiers: NCI-2009-00113CDR0000433404PHII-577003N01CM62208N01CM62201N01CM62209N01CM62207
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Progression-free Survival

  Up to 5 years

• Overall Survival

  Up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.

Drug: bortezomib

Interventions

bortezomib DRUG

Given IV

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• David Gandara

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 21, 2014
• Results First Posted: August 21, 2014

Record last verified: 2013-04

Locations

US (1)