Clinical trial NCT00517829: Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer Adenocarcinoma Metastatic
Keywords: metastatic gastric or adenocarcinoma of the GE junction
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: Sanofi
First posted: 2007-08-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Treatment will continue until disease progression or intolerable toxicity, up to 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: Treatment will continue until disease progression or intolerable toxicity
measure: Objective Response Rate (ORR)
timeFrame: Treatment will continue until disease progression or intolerable toxicity.
measure: Time to Response
timeFrame: Treatment will continue until disease progression or intolerable toxicity
measure: Duration of Response
timeFrame: Treatment will continue until disease progression or intolerable toxicity
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Center - Midtown
state: Colorado
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Chicago
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Centers - Southwest
state: Kansas
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Hudson
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Boardman
country: United States
facility: Mahoning Valley Hematology Oncology Associates
state: Ohio
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Amarillo
country: United States
facility: Texas Oncology, P.A. Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Austin
country: United States
facility: Texas Oncology Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A. - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Methodist Charlton Cancer Ctr.
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Garland
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Lewisville
country: United States
facility: Lake Vista Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: Texas Oncology - Odessa
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer and Research
state: Texas
city: Arlington
country: United States
facility: Fairfax Northern VA Hem-Onc PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Associates of SW VA, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center - Edmonds
state: Washington
city: Kennewicke
country: United States
facility: Columbia Basin Hematology & Oncology
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Center - Seattle
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest - South
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialist - Vancouver
state: Washington
Study officials:
affiliation: US Oncology Research
name: Donald A Richards, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.