Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer Selected stage IIIB (malignant pleural effusion) or stage IV disease Recurrent disease after first-line therapy allowed Patients who received prior platinum-based chemotherapy must have no disease progression during or within 3 months after completion of therapy Patients who are enrolled at the maximum tolerated dose must have chemotherapy-naïve disease Evaluable disease Asymptomatic brain metastases allowed if treated with surgical resection or radiotherapy, neurologically stable, and off steroids for at least 4 weeks Performance status - Karnofsky 60-100% More than 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL AST no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 50 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 2 or greater No prior allergic reactions to compounds of similar chemical or biological composition to bortezomib or other agents used in this study No concurrent ongoing or active infection No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No concurrent routine filgrastim (G-CSF) See Disease Characteristics No more than 1 prior chemotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No prior gemcitabine See Disease Characteristics See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered See Disease Characteristics More than 30 days since prior investigational drugs No prior bortezomib No concurrent anticonvulsant therapy No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies with intent to treat malignancy
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Experimental
Treatment (gemcitabine hydrochloride, carboplatin, bortezomib)
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses.