CompletedPhase 1 / Phase 2NCT00093756

Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer

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.

Checked against the public recordLast updated Dec 7, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations143
SponsorNational Cancer Institute (NCI)
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Radiation: 3-dimensional conformal radiation therapy; Drug: bortezomib; Drug: paclitaxel; Drug: carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic in ArizonaScottsdale, Arizona
  • Saint Francis Hospital and Medical CenterHartford, Connecticut
  • Mayo Clinic in FloridaJacksonville, Florida
  • Rush - Copley Medical CenterAurora, Illinois
  • Illinois CancerCare-BloomingtonBloomington, Illinois
  • Saint Joseph Medical CenterBloomington, Illinois
  • Graham Hospital AssociationCanton, Illinois
  • Illinois CancerCare-CantonCanton, Illinois
  • Illinois CancerCare-CarthageCarthage, Illinois
  • Memorial HospitalCarthage, Illinois
  • Saint Anthony Memorial HospitalEffingham, Illinois
  • Eureka HospitalEureka, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2017. Always confirm current availability with the study team.

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