Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
Completed · Phase 1/Phase 2
Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
In brief
This phase I/II trial (phase I closed to accrual as of 09/29/2009) is studying the side effects and best dose of bortezomib, paclitaxel, and carboplatin when given with radiation therapy and to see how well they work in treating patients with stage IIIA or stage IIIB non-small cell lung cancer that cannot be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of paclitaxel and carboplatin by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving bortezomib, paclitaxel, and carboplatin together with radiation therapy may kill more tumor cells.
Key facts
- Study ID
- NCT00093756
- Run by
- National Cancer Institute (NCI)
- People needed
- 52
- Starts
- 2004-09-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-12-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Locally advanced stage IIIA or IIIB disease that is considered unresectable
- No stage IV disease
- Requires radiotherapy
- Performance status (PS) - Eastern Cooperative Oncology Group (ECOG) 0-1
- At least 12 weeks
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- aspartate aminotransferase (AST) ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Forced expiratory volume (FEV) FEV_1 ≥ 1 L OR 35% of predicted
- Weight loss < 10% within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy ≥ grade 2
- No other severe underlying disease that would preclude study participation
- No uncontrolled infection
- No unhealed wound within the past 2 weeks
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- No prior systemic chemotherapy for NSCLC*
- No prior radiotherapy to the chest
Where it is running
- Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Rush - Copley Medical Center — Aurora, Illinois, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Saint Joseph Medical Center — Bloomington, Illinois, United States
- Graham Hospital Association — Canton, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Memorial Hospital — Carthage, Illinois, United States
- Saint Anthony Memorial Hospital — Effingham, Illinois, United States
- Eureka Hospital — Eureka, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Galesburg Cottage Hospital — Galesburg, Illinois, United States
- Illinois CancerCare Galesburg — Galesburg, Illinois, United States
- Western Illinois Cancer Treatment Center — Galesburg, Illinois, United States
- Illinois CancerCare-Havana — Havana, Illinois, United States
- Mason District Hospital — Havana, Illinois, United States
- Hopedale Medical Complex - Hospital — Hopedale, Illinois, United States
- Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Kewanee Hospital — Kewanee, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Mcdonough District Hospital — Macomb, Illinois, United States
- Holy Family Medical Center — Monmouth, Illinois, United States
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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