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Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

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ClinicalTrials.gov Identifier: NCT00517829
Recruitment Status : Completed
First Posted : August 17, 2007
Results First Posted : February 11, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborators:
Eli Lilly and Company
Sanofi
Information provided by (Responsible Party):
US Oncology Research

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Adenocarcinoma Metastatic Drug: Docetaxel Drug: cetuximab Drug: oxaliplatin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
Study Start Date : July 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1- Docetaxel plus Oxaliplatin
Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours
Drug: Docetaxel
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
Other Name: Taxotere (docetaxel)

Drug: oxaliplatin
Eloxatin 130 mg/m2 IV over 2 hours
Other Name: Eloxatin (oxaliplatin)

Active Comparator: 2- Docetaxel plus oxaliplatin plus cetuximab
Docetaxel 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.
Drug: Docetaxel
Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour
Other Name: Taxotere (docetaxel)

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

Drug: oxaliplatin
Eloxatin 130 mg/m2 IV over 2 hours
Other Name: Eloxatin (oxaliplatin)




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Treatment will continue until disease progression or intolerable toxicity, up to 2 years ]

    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.



Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Treatment will continue until disease progression or intolerable toxicity ]
    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.

  2. Objective Response Rate (ORR) [ Time Frame: Treatment will continue until disease progression or intolerable toxicity. ]
    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.

  3. Time to Response [ Time Frame: Treatment will continue until disease progression or intolerable toxicity ]
    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.

  4. Duration of Response [ Time Frame: Treatment will continue until disease progression or intolerable toxicity ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517829


  Hide Study Locations
Locations
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United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
United States, Colorado
Rocky Mountain Cancer Center - Midtown
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
United States, Illinois
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States, 60611
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Hope Center
Terre Haute, Indiana, United States, 47802
United States, Kansas
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
United States, New York
New York Oncology Hematology, P.C.
Hudson, New York, United States, 12534
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14623
United States, North Carolina
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Mahoning Valley Hematology Oncology Associates
Boardman, Ohio, United States, 44514
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
United States, Texas
Texas Oncology, P.A. Amarillo
Amarillo, Texas, United States, 79106
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Oncology, P.A. - Bedford
Bedford, Texas, United States, 76022
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Texas Oncology, P.A.
Dallas, Texas, United States, 75231
Methodist Charlton Cancer Ctr.
Dallas, Texas, United States, 75237
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Texas Cancer Center
Denton, Texas, United States, 76210
El Paso Cancer Treatment Ctr
El Paso, Texas, United States, 79915
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Texas Oncology, P.A.
Garland, Texas, United States, 75042
Lake Vista Cancer Center
Lewisville, Texas, United States, 75067
Longview Cancer Center
Longview, Texas, United States, 75601
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Allison Cancer Center
Midland, Texas, United States, 79701
Texas Oncology - Odessa
Odessa, Texas, United States, 79761
Paris Regional Cancer Center
Paris, Texas, United States, 75460
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology Cancer and Research
Waco, Texas, United States, 76712
United States, Virginia
Fairfax Northern VA Hem-Onc PC
Arlington, Virginia, United States, 22205
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Cancer Center - Edmonds
Edmonds, Washington, United States, 98026
Columbia Basin Hematology & Oncology
Kennewicke, Washington, United States, 99336
Puget Sound Cancer Center - Seattle
Seattle, Washington, United States, 98133
Cancer Care Northwest - South
Spokane, Washington, United States, 99202
Northwest Cancer Specialist - Vancouver
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
US Oncology Research
Eli Lilly and Company
Sanofi
Investigators
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Principal Investigator: Donald A Richards, MD US Oncology Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00517829     History of Changes
Other Study ID Numbers: 06063
First Posted: August 17, 2007    Key Record Dates
Results First Posted: February 11, 2016
Last Update Posted: November 28, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by US Oncology Research:
metastatic gastric or adenocarcinoma of the GE junction
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Oxaliplatin
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological