A Phase II Study Of PS-341 In Metastatic Non-Small Cell Lung Cancer
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
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.
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer
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
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