CompletedPhase 2NCT00003762

Docetaxel and Gemcitabine in Treating Patients With Stage IIIB or Stage IV 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: Randomized phase II trial to compare the effectiveness of two regimens of docetaxel plus gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Checked against the public recordLast updated Jul 13, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations17
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: docetaxel; 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 or cytologically confirmed stage IIIB/IV nonsmall cell lung cancer eligible for first line chemotherapy Measurable disease (must be outside radiation port or proof of progressive disease) Metastatic CNS disease allowed if treated and stable for at least 21 days prior to study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: At least 3 months since prior myocardial infarction No uncontrolled congestive heart failure No uncontrolled arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception Peripheral neuropathy less than grade 2 No history of hypersensitivity to products containing polysorbate 80 No other significant medical condition No meningeal carcinomatosis No weight loss of greater than 10% within past 3 months due to disease PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy to pelvis, spine, or long bones and recovered No prior radiotherapy to at least 30% of bone marrow Surgery: Greater than 4 weeks since prior major surgery Other: At least 3 weeks since prior investigational drugs

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

  • CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
  • CCOP - Carle Cancer CenterUrbana, Illinois
  • CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
  • CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
  • Siouxland Hematology-OncologySioux City, Iowa
  • CCOP - WichitaWichita, Kansas
  • CCOP - Ann Arbor RegionalAnn Arbor, Michigan
  • CCOP - DuluthDuluth, Minnesota
  • Mayo Clinic Cancer CenterRochester, Minnesota
  • CentraCare ClinicSaint Cloud, Minnesota
  • CCOP - Metro-MinnesotaSaint Louis Park, Minnesota
  • CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.

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