Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT00040768 | Terminated Phase 2

• 3 other identifiers: NCI-2012-02470UPCC 06501CDR0000069405
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of bortezomib in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer. Bortezomib may interfere with the growth of tumor cells by blocking certain enzymes necessary for tumor cell growth

Conditions

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)

• Overall response rate to PS-341 therapy

  Up to 4 years

Secondary Outcomes (2)

• Progression-free survival

  Up to 4 months

• Overall survival

  Up to 4 hours

Study Arms (1)

Treatment (bortezomib)

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who received prior bortezomib and achieved at least a partial response of at least 6 months duration may also receive therapy as above.

Drug: bortezomib

Interventions

bortezomib DRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE

Treatment (bortezomib)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed non-small cell lung cancer
• Mixed tumors allowed unless small cell elements are present
• Stage IIIB or IV or recurrent disease
• At least 1 measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known brain metastases
• Performance status - ECOG 0-1
• More than 3 months
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 2 mg/dL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver involvement present)
• Creatinine ≤ 2 mg/dL
• Creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; 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

Study Officials

• James Stevenson

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

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, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: March 1, 2006
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)