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CompletedPhase 1NCT00032032
Official study title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 1, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?51 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
02
Explore related studies

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)→
Treatment approach
Chemotherapy→Radiation therapy→Surgery→
03
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
  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
  • Measurable disease
  • Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
  • No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
  • No more than small effusions seen on chest CT scan only
  • No supraclavicular adenopathy PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-1 Life expectancy:
  • At least 12 weeks Hematopoietic:
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin no greater than 1.5 times ULN
  • AST no greater than 3 times ULN Renal:
  • Creatinine clearance at least 40 mL/min Cardiovascular:
  • No New York Heart Association class III or IV heart disease Pulmonary:
  • FEV\_1 at least 1 L or 35% of predicted Other:
  • No grade 2 or greater peripheral neuropathy
  • No weight loss of 10% or more within the past 3 months
  • No uncontrolled infection
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
  • No other severe underlying disease that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic:
  • No prior biologic therapy for NSCLC
  • No concurrent biologic therapy
  • No concurrent prophylactic filgrastim (G-CSF) Chemotherapy:
  • No prior chemotherapy for NSCLC
  • No other concurrent chemotherapy Endocrine therapy:
  • No prior endocrine therapy for NSCLC Radiotherapy:
  • No prior radiotherapy for NSCLC Surgery:
  • No prior surgery for NSCLC

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 ScottsdaleScottsdale, Arizona
  • Mayo Clinic - JacksonvilleJacksonville, Florida
  • McFarland Clinic, PCAmes, Iowa
  • Mercy Capitol HospitalDes Moines, Iowa
  • CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
  • John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa
  • Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa
  • Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa
  • Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa
  • John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa
  • Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa
  • Mercy Medical Center - Sioux CitySioux City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 1, 2016. Always confirm current availability with the study team.

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