Clinical trial NCT00087802: Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-07-16
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates - Hematology Oncology Physicians
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Plantation
country: United States
facility: South Florida Oncology & Hematology Consultants
state: Florida
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Niles
country: United States
facility: Northwest Medical Specialists, PC
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Cedar Rapids
country: United States
facility: Oncology Associates of Cedar Rapids
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Oncology and Hematology Group
state: Kansas
city: Columbia
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology, PC
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: St. Louis
country: United States
facility: Arch Medical Services, Inc.
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Latham
country: United States
facility: New York Oncology Hematology
state: New York
city: Rexford
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology & Hematology, P.C.
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Oncology Associates, PLLC.
state: North Carolina
city: Kettering
country: United States
facility: Dayton Oncology & Hematology, P.A.
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Abilene
country: United States
facility: Texas Cancer Center - Abilene
state: Texas
city: Arlington
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: The Texas Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center - Denton
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr-East
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fredericksburg
country: United States
facility: San Antonio Tumor and Blood Clinic
state: Texas
city: Garland
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Houston
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Irving
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Lewisville
country: United States
facility: Lake Vista Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: McAllen
country: United States
facility: South Texas Cancer Center - McAllen
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Hematology Oncology Associates of South Texas
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center - Sherman
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Waco Cancer Care and Research Center
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology Oncology, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
Study officials:
affiliation: Sanofi
name: Yasir Nagarwala, MD
role: STUDY_DIRECTOR
References: