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
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
Status | Terminated |
Enrollment | 35 |
Est. completion date | |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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 |
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