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Carcinoma, Non-Small-Cell LungPhase 3NCT00087802

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

A Phase 3 study testing gemcitabine/Eloxatin (GEMOX) and carboplatin/paclitaxel (CP) in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi at 70 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
gemcitabine/Eloxatin (GEMOX) and carboplatin/paclitaxel (CP)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
383 participants
Where
70 sitesUnited States
Study dates
Mar 2004to May 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

70 sites in 1 country.

70 sites in 1 country

United States70 sites

  • Texas Cancer Center - Abilene

    Abilene, Texas, 79606

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Texas Oncology, P.A.

    Arlington, Texas, 76012

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35235

  • Birmingham Hematology and Oncology Associates

    Birmingham, Alabama, 35235

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • Oncology Associates of Cedar Rapids

    Cedar Rapids, Iowa, 52403

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230-2510

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • The Texas Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center - Denton

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr-East

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Fairfax Northern Virginia Hematology Oncology, PC

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • San Antonio Tumor and Blood Clinic

    Fredericksburg, Texas, 78624

  • Texas Oncology, P.A.

    Garland, Texas, 75042-5788

  • Texas Oncology, P.A.

    Houston, Texas, 77024

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Texas Oncology, P.A.

    Irving, Texas, 75061-2244

  • Dayton Oncology & Hematology, P.A.

    Kettering, Ohio, 45409

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • New York Oncology Hematology

    Latham, New York, 12110

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cancer Center

    Longview, Texas, 75601

  • South Texas Cancer Center - McAllen

    McAllen, Texas, 78503-1298

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701-5946

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

  • Florida Cancer Institute

    New Port Richey, Florida, 34652

  • Northwest Medical Specialists, PC

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.

    Ocoee, Florida, 34761

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • Kansas City Oncology and Hematology Group

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts, 01201

  • South Florida Oncology & Hematology Consultants

    Plantation, Florida, 33324

  • New York Oncology Hematology, P.C.

    Rexford, New York, 12148

  • Interlakes Oncology & Hematology, P.C.

    Rochester, New York, 14623

  • Oncology & Hematology Associates of Southwest Virginia, Inc.

    Salem, Virginia, 24153

  • Hematology Oncology Associates of South Texas

    San Antonio, Texas, 78229

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Puget Sound Cancer Centers

    Seattle, Washington, 98133

  • Northern Arizona Hematology & Oncology Associates

    Sedona, Arizona, 86336

  • Cancer Centers of the Carolinas

    Seneca, South Carolina, 29672

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090-0504

  • Hematology Oncology Associates of Illinois

    Skokie, Illinois, 60077

  • Cancer Care Northwest

    Spokane, Washington, 99218

  • Arch Medical Services, Inc.

    St Louis, Missouri, 63141

  • Arizona Oncology Associates - Hematology Oncology Physicians

    Tucson, Arizona, 85704

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136-1902

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Waco Cancer Care and Research Center

    Waco, Texas, 76712

  • Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Piedmont Hematology Oncology Associates, PLLC.

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this 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)

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).

Being tested
gemcitabine/Eloxatin (GEMOX), carboplatin/paclitaxel (CP)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine/Eloxatin (GEMOX)Drug

    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]

  • carboplatin/paclitaxel (CP)Drug

    CP [carboplatin/paclitaxel - 21 day cycle]

    • 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]
Study groups in NCT00087802
Study groupRoleWhat they receive
Stratum 1Active comparatorSubjects 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
Receives: Drug: gemcitabine/Eloxatin (GEMOX)
Stratum 2Active comparatorSubjects 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).
Receives: Drug: carboplatin/paclitaxel (CP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087802
Sponsor's protocol ID
L_9210
Other IDs
SR96669
Status last verified
Apr 2009
First submitted
13 Jul 2004
Last updated
16 Apr 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine/Eloxatin (GEMOX) and carboplatin/paclitaxel (CP) in people with Carcinoma, Non-Small-Cell Lung, run by Sanofi at 70 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2009.

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