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Gastric Cancer Adenocarcinoma MetastaticPhase 2NCT00517829

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

A Phase 2 study testing Docetaxel, cetuximab and oxaliplatin in people with Gastric Cancer Adenocarcinoma Metastatic, run by US Oncology Research at 47 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 research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer Adenocarcinoma Metastatic
What is being tested?
Docetaxel, cetuximab and oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
47 sitesUnited States
Study dates
Jul 2007to Apr 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patient has histologically confirmed Stage IV adenocarcinoma of the GEJ/stomach
  • Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
  • Patients must have measurable disease
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
  • Patient is greater than 18 years of age
  • If present, any pre-existing (current) peripheral neuropathy must be ≤ Grade 1
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  • Patient's laboratory values must fall within the limits set forth in section 4.2 of the protocol
  • Patient has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a 2 month period thereafter
  • Patient (or guardian) has signed a Patient Informed Consent Form
  • Patient (or guardian) has signed a Patient Authorization Form

Who cannot join

  • Patient has any metastatic disease other than that defined in section 4.2 (criterion #1)
  • Patient has had prior treatment that included anything other than adjuvant radiation plus treatment with 5-FU and leucovorin. Prior treatment must have been completed > 6 months prior to registration in current study. No other prior regimens are allowed.
  • Note: Adjuvant radiation plus treatment with 5-FU and leucovorin is permitted, but not required.
  • If present, any peripheral neuropathy is > Grade 1
  • Patient has a known hypersensitivity to Taxotere (or any drug formulated with Polysorbate-80), or Eloxatin
  • Has had a prior severe infusion reaction (Grade 4) to a monoclonal antibody
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  • Has received prior therapy, at any time, which specifically and directly targets the EGFR pathway
  • Patient is receiving concurrent immunotherapy or any other concurrent treatment for their cancer
  • Has had prior stem cell or bone marrow transplant or any organ transplant with the exception of corneal transplant or cadaver bone graft
  • Has a significant history of uncontrolled cardiac disease; ie, uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, or cardiomyopathy with decreased ejection fraction (LVEF<50%)
  • Has evidence of CNS involvement (CNS imaging is not required for study enrollment unless clinically suspected CNS disease is present.)
  • Patient has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  • Patient is known to be HIV positive or have a history of hepatitis B or C
  • Patient has a 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), which could affect the diagnosis or assessment of current condition.
  • Patient is a pregnant or lactating woman

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Texas Oncology, P.A. Amarillo

    Amarillo, Texas, 79106

  • Texas Cancer Center

    Arlington, Texas, 76014

  • Fairfax Northern VA Hem-Onc PC

    Arlington, Virginia, 22205

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology, P.A. - Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Mahoning Valley Hematology Oncology Associates

    Boardman, Ohio, 44514

  • Hematology Oncology Associates of Illinois

    Chicago, Illinois, 60611

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • Methodist Charlton Cancer Ctr.

    Dallas, Texas, 75237

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center - Midtown

    Denver, Colorado, 80218

  • Puget Sound Cancer Center - Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Ctr

    El Paso, Texas, 79915

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • New York Oncology Hematology, P.C.

    Hudson, New York, 12534

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Columbia Basin Hematology & Oncology

    Kennewicke, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates

    Kingston, Pennsylvania, 18704

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Longview Cancer Center

    Longview, Texas, 75601

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Texas Oncology - Odessa

    Odessa, Texas, 79761

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • Onc and Hem Associates of SW VA, Inc.

    Salem, Virginia, 24153

  • Puget Sound Cancer Center - Seattle

    Seattle, Washington, 98133

  • Cancer Care Northwest - South

    Spokane, Washington, 99202

  • Hope Center

    Terre Haute, Indiana, 47802

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialist - Vancouver

    Vancouver, Washington, 98684

  • Texas Oncology Cancer and Research

    Waco, Texas, 76712

Other trials in United States

About this study

Official title: Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma

The purpose of this research study is to find out what effects (good and bad) docetaxel, oxaliplatin, and cetuximab have on gastric or GEJ cancer.

Read the detailed description

This is a Phase II, open- label, randomized, noncomparative study. Patients will be stratified at randomization by ECOG PS. There is no intent to have equal numbers of patients for each PS (ie, 0, 1, and 2), but rather stratification will be conducted to ensure that the 2 treatment arms are well-balanced for ECOG PS.

Patients will be randomly assigned to either Arm 1 - Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour, followed by Eloxatin 130 mg/m2 IV over 2 hours or Arm 2 - Taxotere 60 mg/m2 as an IV infusion over 1 ho ur, followed by Eloxatin 130mg/m2 IV over 2 hours, followed by ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes. Taxotere and Eloxatin will be given on Day 1 of each 21-day cycle; ERBITUX is given on Days 1, 8, and 15 of each cycle.

Treatment will continue until disease progression or intolerable toxicity. Patients who achieve a CR will receive an additional 2 cycles of treatment. Patients will be limited to 24 months of participation, counted from the date of the first dose of study drug.

Keywords
metastatic gastric or adenocarcinoma of the GE junction

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere (docetaxel)

    Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour

  • cetuximabDrug

    Also called ERBITUX (cetuximab)

    ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.

  • oxaliplatinDrug

    Also called Eloxatin (oxaliplatin)

    Eloxatin 130 mg/m2 IV over 2 hours

Study groups in NCT00517829
Study groupRoleWhat they receive
1- Docetaxel plus OxaliplatinActive comparatorDocetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours
Receives: Drug: Docetaxel; Drug: oxaliplatin
2- Docetaxel plus oxaliplatin plus cetuximabActive comparatorDocetaxel 60 mg/m2 as an IV infusion over 1 ho ur, followed by oxaliplatin 130 mg/m2 IV over 2 hours, followed by cetuximab 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.
Receives: Drug: Docetaxel; Drug: cetuximab; Drug: oxaliplatin

What is being measured

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

  1. Progression-free Survival

    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Treatment will continue until disease progression or intolerable toxicity, up to 2 years

Secondary outcomes (4)

  1. Overall Survival

    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: Treatment will continue until disease progression or intolerable toxicity

  2. Objective Response Rate (ORR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: Treatment will continue until disease progression or intolerable toxicity.

  3. Time to Response

    For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

    Measured: Treatment will continue until disease progression or intolerable toxicity

  4. Duration of Response

    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

    Measured: Treatment will continue until disease progression or intolerable toxicity

Timeline

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

  1. First posted17 Aug 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2012
  4. Study completionApr 2012

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00517829
Sponsor's protocol ID
06063
Status last verified
Oct 2016
First submitted
15 Aug 2007
Last updated
28 Nov 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • Richards D, Kocs DM, Spira AI, David McCollum A, Diab S, Hecker LI, Cohn A, Zhan F, Asmar L. Results of docetaxel plus oxaliplatin (DOCOX) +/- cetuximab in patients with metastatic gastric and/or gastroesophageal junction adenocarcinoma: results of a randomised Phase 2 study. Eur J Cancer. 2013 Sep;49(13):2823-31. doi: 10.1016/j.ejca.2013.04.022. Epub 2013 Jun 5.

    PubMed 23747051

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, cetuximab and oxaliplatin in people with Gastric Cancer Adenocarcinoma Metastatic, run by US Oncology Research at 47 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 11 inclusion and 15 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (time frame: Treatment will continue until disease progression or intolerable toxicity, up to 2 years). 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 NCT00517829, which also lists 1 linked publication.

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 28 Nov 2016.

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