Status:
COMPLETED
Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ho...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of bortezomib, paclitaxel, and carboplatin when administered with fractionated radiotherapy in patients with unresectable stage IIIA or III...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- More than 2 weeks since prior major surgery
- Contraindications
- Any of the following:
- Pregnant wome
- Nursing women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.) as this regimen may be harmful to a developing fetus or nursing child NOTE: This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Any of the following prior therapies:
- Prior radiation therapy to the chest
- Prior systemic chemotherapy for NSCLC (phase II portion)
- New York Heart Association classification III or IV (see Appendix II).
- Any other severe underlying diseases which are, in the judgment of the investigator, inappropriate for entry into this study.
- uncontrolled infection.
- Major surgery or unhealed wound ≤ 2 weeks prior to registration.
- Prior history of malignancy ≤ 5 years, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas (carcinoma in situ), or localized prostate cancer.
- Peripheral neuropathy ≥grade 2
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00093756
Start Date
September 1 2004
End Date
May 1 2013
Last Update
December 7 2017
Active Locations (143)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
3
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
4
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504