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A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive

- One (1) unidimensionally measurable lesion

- ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1

- Patients with clinically stable brain metastases on a stable dose of (or no longer
requiring) dexamethasone at registration will be eligible. Patients who have received
cranial radiation for brain metastases must be at least 4 weeks from last radiation
treatment.

- Recovery in full from any previous surgical procedure

- No history of an acute cardiac or CNS event within 6 months of entry or current
clinical evidence of congestive heart failure or non-stable coronary artery disease

Exclusion Criteria:

- Hypersensitivity to any of the 4 study drugs

- Concurrent immunotherapy or participation in any investigational drug study within 4
weeks

- Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft

- History of other malignancy within the last 5 years (except for squamous or basal
cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial
transitional cell carcinoma of the bladder)

- Patient is a pregnant or lactating female

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC

Outcome Time Frame:

22 months

Principal Investigator

Yasir Nagarwala, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

L_9210

NCT ID:

NCT00087802

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Rocky Mountain Cancer CentersThornton, Colorado  80260
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Berkshire Hematology Oncology, PCPittsfield, Massachusetts  01201
Oncology Associates of Cedar RapidsCedar Rapids, Iowa  52403
Cancer Care AssociatesTulsa, Oklahoma  74136
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
San Antonio Tumor and Blood ClinicSan Antonio, Texas  78217
New York Oncology Hematology, P.C.Albany, New York  12208
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Interlakes Oncology & Hematology, P.C.Rochester, New York  14623
Cancer Centers of Florida, P.A.Orlando, Florida  
Raleigh Hematology Oncology ClinicCary, North Carolina  27511
Florida Cancer InstituteNew Port Richey, Florida  34652
South Florida Oncology & Hematology ConsultantsPlantation, Florida  33324
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
New York Oncology HematologyAlbany, New York  12208
Hematology Oncology AssociatesPhoenix, Arizona  85012
Arch Medical Services, INC.St. Louis, Missouri  63142
Northwest Cancer Specialists, P.C.Vancouver, Washington  
Texas Oncology Cancer CenterAustin, Texas  78731
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
The Texas Cancer CenterDallas, Texas  75237
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Hematology Oncology Associates of South TexasSan Antonio, Texas  78229
Kansas City Oncology and Hematology GroupKansas City, Kansas  66112
Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama  35235
Northern Arizona Hematology & Oncology AssociatesSedona, Arizona  86336
Northwest Medical Specialists, PCNiles, Illinois  60714
Deke Slayton Cancer CenterWebster, Texas  77589
Puget Sound Cancer CentersEdmonds, Washington  98026
Birmingham Hematology and Oncology AssociatesBirmingham, Alabama  35235
Arizona Oncology Associates - Hematology Oncology PhysiciansTucson, Arizona  85704
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Minnesota Oncology HematologyMinneapolis, Minnesota  55404
Piedmont Hematology Oncology Associates, PLLC.Winston-Salem, North Carolina  27103
Dayton Oncology & Hematology, P.A.Kettering, Ohio  45409
Texas Cancer Center - AbileneAbilene, Texas  79606
Texas Cancer Center - DentonDenton, Texas  76210
El Paso Cancer Treatment Ctr-EastEl Paso, Texas  79915
South Texas Cancer Center - McAllenMcAllen, Texas  78503-1298
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
Waco Cancer Care and Research CenterWaco, Texas  76712
Fairfax Northern Virginia Hematology Oncology, PCFairfax, Virginia  22031
Oncology & Hematology Associates of Southwest Virginia, Inc.Salem, Virginia  24153