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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040768
• Other study ID #: NCI-2012-02470
• Secondary ID: UPCC 06501CDR000
• Status: Terminated
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: January 15, 2013
• Start date: April 2002

Study information

• Verified date: January 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

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

Description:

PRIMARY OBJECTIVES:

I. Determine the response rate, time to progression, and survival of patients with advanced non-small cell lung cancer treated with bortezomib.

II. Determine the toxicity of this drug in these patients. III. Correlate toxicity and activity of this drug with markers of proteasome inhibition in blood and peripheral mononuclear cells in these patients.

OUTLINE:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No peripheral neuropathy > grade 1

• No other concurrent uncontrolled illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study participation

• No more than 1 prior chemotherapy regimen

• Two prior chemotherapy regimens allowed provided 1 of the 2 regimens was gefitinib monotherapy as second-line therapy

• At least 4 weeks since prior chemotherapy (6 weeks for carmustine, mitomycin, or nitrosoureas) and recovered

• At least 4 weeks since prior radiotherapy (except localized radiotherapy for symptom relief) and recovered

• Prior bortezomib allowed provided patient achieved at least a partial response (of at least 6 months duration), received no other therapy since the last dose of bortezomib, and has no residual toxicity greater than grade 1

• No other concurrent investigational or commercial agents or therapies for malignancy

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania

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	Overall response rate to PS-341 therapy		Up to 4 years	No
Secondary	Progression-free survival	Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.	Up to 4 months	No
Secondary	Overall survival	Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.	Up to 4 hours	No