CompletedPhase 2NCT00792701

S0720: Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery.

Checked against the public recordLast updated Mar 6, 2020 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations147
SponsorSWOG Cancer Research Network
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SWOG Cancer Research Network
Interventions being studied
Drug: cisplatin; 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.

03
Public criteria

Who may be able to participate

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage IA (longest tumor diameter 2-3 cm) or stage IB disease * Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery * A whole body PET scan or a combined PET/CT must be performed within 84 days * Any finding on PET scan that clinically suggests N1, N2, N3, or M1 disease must have been cleared by further evaluation, including, but not limited to, any of the following: * Ultrasonography, X-ray radiology, magnetic resonance imaging, or nuclear medicine imaging * Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days * Completely excised primary lesion with negative gross and microscopic margins * At least two mediastinal lymph node stations sampled * Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue PATIENT CHARACTERISTICS: * Zubrod performance status 0-1 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 mg/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except for the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I-II cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years * Willing to provide prior smoking history PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior systemic chemotherapy or biologic therapy for lung cancer * No prior thoracic radiation therapy (RT) (including RT to the chest wall) * No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy * Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed

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

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFort Smith, Arkansas
  • City of Hope Comprehensive Cancer CenterDuarte, California
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California
  • Valley Medical Oncology Consultants - PleasantonPleasanton, California
  • Sutter Cancer Center at Roseville Medical CenterRoseville, California
  • Sutter Cancer CenterSacramento, California
  • University of California Davis Cancer CenterSacramento, California
  • Tahoe Forest Cancer CenterTruckee, California
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut
  • Northeast Georgia Medical CenterGainesville, Georgia
  • Tripler Army Medical CenterHonolulu, Hawaii
  • Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 6, 2020. Always confirm current availability with the study team.

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