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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

Tracking Information
First Submitted Date  ICMJE August 15, 2007
First Posted Date  ICMJE August 17, 2007
Results First Submitted Date  ICMJE January 12, 2016
Results First Posted Date  ICMJE February 11, 2016
Last Update Posted Date November 28, 2016
Study Start Date  ICMJE July 2007
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00517829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
Official Title  ICMJE Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer Adenocarcinoma Metastatic
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: 1- Docetaxel plus Oxaliplatin
    Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours
    Interventions:
    • Drug: Docetaxel
    • Drug: 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: cetuximab
    • Drug: oxaliplatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
150
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00517829
Other Study ID Numbers  ICMJE 06063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party US Oncology Research
Study Sponsor  ICMJE US Oncology Research
Collaborators  ICMJE
  • Eli Lilly and Company
  • Sanofi
Investigators  ICMJE
Principal Investigator: Donald A Richards, MD US Oncology Research
PRS Account US Oncology Research
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP