search
Back to results

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

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of The University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (bortezomib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall response rate to PS-341 therapy

Secondary Outcome Measures

Progression-free survival
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.
Overall survival
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.

Full Information

First Posted
July 8, 2002
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00040768
Brief Title
Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title
A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (bortezomib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bortezomib
Other Intervention Name(s)
LDP 341, MLN341, VELCADE
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall response rate to PS-341 therapy
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.
Time Frame
Up to 4 months
Title
Overall survival
Description
Kaplan-Meier estimates of survival (overall, progression free) and 95% confidence intervals will be calculated.
Time Frame
Up to 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Stevenson
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs