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CompletedPhase 2NCT00041314
Official study title

Combination Chemotherapy in Treating Patients With Advanced 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and exisulind

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 Jun 15, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?79 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Drug: carboplatin; Drug: exisulind; Drug: gemcitabine hydrochloride
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→
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 confirmed non-small cell lung cancer (NSCLC)
  • Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR
  • Stage IV
  • Prior brain metastases are allowed provided the following are true:
  • Patient completed radiotherapy and/or surgery at least 3 weeks prior to study
  • Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI
  • Patient is neurologically improved or stable PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-1 Life expectancy:
  • Not specified Hematopoietic:
  • Absolute granulocyte count at least 1,500/mm\^3
  • WBC at least 3,000/mm\^3
  • Hemoglobin at least 9 g/L
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • Bilirubin no greater than 1.25 mg/dL
  • SGOT no greater than 1.5 times upper limit of normal Renal:
  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min Cardiovascular:
  • No prior uncontrolled cardiovascular disease
  • No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months Other:
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No serious active infection
  • No dementia or active psychoses
  • No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • No prior chemotherapy Endocrine therapy:
  • Not specified Radiotherapy:
  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy Surgery:
  • See Disease Characteristics Other:
  • At least 1 month since prior investigational agents
  • More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)
  • No concurrent sulindac or COX-2 inhibitors

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

  • University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama
  • CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
  • City of Hope Comprehensive Cancer CenterDuarte, California
  • Veterans Affairs Medical Center - Palo AltoPalo Alto, California
  • Stanford University Medical CenterStanford, California
  • CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado
  • CCOP - Christiana Care Health ServicesWilmington, Delaware
  • MBCCOP-Howard University Cancer CenterWashington D.C., District of Columbia
  • Veterans Affairs Medical Center - GainesvilleGainesville, Florida
  • Veterans Affairs Medical Center - MiamiMiami, Florida
  • H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida
  • Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 15, 2023. Always confirm current availability with the study team.

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