Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer Adenocarcinoma Metastatic
• Intervention / Treatment: Drug: Docetaxel; Drug: oxaliplatin; Drug: cetuximab

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: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Taxotere (docetaxel); Drug: oxaliplatin; Eloxatin 130 mg/m2 IV over 2 hours; Other Names: 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 Names: Taxotere (docetaxel); Drug: oxaliplatin; Eloxatin 130 mg/m2 IV over 2 hours; Other Names: Eloxatin (oxaliplatin); Drug: cetuximab; ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.; Other Names: ERBITUX (cetuximab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Treatment will continue until disease progression or intolerable toxicity, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Treatment will continue until disease progression or intolerable toxicity
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.	Treatment will continue until disease progression or intolerable toxicity.
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.	Treatment will continue until disease progression or intolerable toxicity
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.	Treatment will continue until disease progression or intolerable toxicity

Collaborators and Investigators

• Sponsor: US Oncology Research
• Collaborators: Eli Lilly and Company; Sanofi
• Investigators: Principal Investigator: Donald A Richards, MD, US Oncology Research

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: August 15, 2007
• First Submitted That Met QC Criteria: August 16, 2007
• First Posted (Estimate): August 17, 2007

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: metastatic gastric or adenocarcinoma of the GE junction
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Oxaliplatin; Cetuximab
• Other Study ID Numbers: 06063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO