CompletedPhase 2NCT00041314

Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

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.

Checked against the public recordLast updated Jun 15, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations79
SponsorEastern Cooperative Oncology Group
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
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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

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.

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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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