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

Study 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 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studied3-dimensional conformal radiation therapy and bortezomib

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?143 U.S. locations

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Treatment approach

Chemotherapy→Radiation therapy→Surgery→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

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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