CompletedPhase 2NCT00022646

Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic 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. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.

Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations22
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: gemcitabine hydrochloride; Drug: pemetrexed disodium
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 locally advanced or metastatic non-small cell lung cancer * Stage IIIB disease that is ineligible for combined modality therapy OR * Stage IV disease * Measurable disease * No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures * No brain metastases (even if treated) 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 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine clearance at least 45 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to take folic acid or cyanocobalamin (vitamin B12) supplementation * No uncontrolled infection * No concurrent chronic debilitating disease * No weight loss of 10% or more within the past 6 weeks * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic or genetic therapy for lung cancer * No concurrent immunomodulating agents Chemotherapy: * No prior chemotherapy for lung cancer Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy to a different site and recovered * No prior radiotherapy to 25% or more of bone marrow * No prior radiotherapy to whole pelvis * No prior radiotherapy for primary disease * No concurrent radiotherapy Surgery: * More than 4 weeks since prior major surgery Other: * No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone) * No other concurrent cytostatic or cytotoxic therapy

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
  • Mayo ClinicJacksonville, Florida
  • CCOP - Illinois Oncology Research AssociationPeoria, Illinois
  • 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 Health PlazaSaint Cloud, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.

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