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Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

This study has been completed.
Sponsor:
Collaborators:
ImClone LLC
Sanofi
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00517829
First received: August 15, 2007
Last updated: October 14, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Gastric Cancer Adenocarcinoma Metastatic
Drug: Docetaxel
Drug: cetuximab
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Treatment will continue until disease progression or intolerable toxicity, up to 2 years ] [ Designated as safety issue: No ]

    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:
  • Overall Survival [ Time Frame: Treatment will continue until disease progression or intolerable toxicity ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: July 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517829

  Show 47 Study Locations
Sponsors and Collaborators
US Oncology Research
ImClone LLC
Sanofi
Investigators
Principal Investigator: Donald A Richards, MD US Oncology Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00517829     History of Changes
Other Study ID Numbers: 06063 
Study First Received: August 15, 2007
Results First Received: January 12, 2016
Last Updated: October 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by US Oncology Research:
metastatic gastric or adenocarcinoma of the GE junction

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016