Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC) - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00087802

Purpose

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).

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: gemcitabine/Eloxatin (GEMOX) Drug: carboplatin/paclitaxel (CP)	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Gemcitabine hydrochloride Gemcitabine Paclitaxel Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 [ Time Frame: 22 months ]

Enrollment:	383
Study Start Date:	March 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
Stratum 1: Active Comparator Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally	Drug: gemcitabine/Eloxatin (GEMOX) GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]
Stratum 2: Active Comparator Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).	Drug: carboplatin/paclitaxel (CP) CP [carboplatin/paclitaxel - 21 day cycle] o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]

Arms

Assigned Interventions

Stratum 1: Active Comparator

Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally

Drug: gemcitabine/Eloxatin (GEMOX)

GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]

Stratum 2: Active Comparator

Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).

Drug: carboplatin/paclitaxel (CP)

CP [carboplatin/paclitaxel - 21 day cycle]

o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087802

Show 70 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Yasir Nagarwala, MD

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Study Director )
Study ID Numbers:	L_9210, SR96669
Study First Received:	July 13, 2004
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00087802
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Oxaliplatin
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors

Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009