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Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Information source: US Oncology Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Cancer Adenocarcinoma Metastatic

Intervention: Docetaxel + oxaliplatin (Drug); Docetaxel + oxaliplatin + cetuximab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: US Oncology Research

Official(s) and/or principal investigator(s):
Donald A Richards, MD, Principal Investigator, Affiliation: US Oncology Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the progression-free survival produced by the combination of docetaxel (Taxotere) + oxaliplatin (Eloxatin) + cetuximab (ERBITUX)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Birmingham Hematology and Oncology, Birmingham, Alabama 35205, United States

Hematology Oncology Associates, Phoenix, Arizona 85012, United States

Rocky Mountain Cancer Center - Midtown, Denver, Colorado 80218, United States

Florida Cancer Institute, New Port Richey, Florida 34655, United States

Ocala Oncology Center, Ocala, Florida 34474, United States

Hematology Oncology Associates of Illinois, Chicago, Illinois 60611, United States

Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois 60714, United States

Central Indiana Cancer Centers, Indianapolis, Indiana 46227, United States

Hope Center, Terre Haute, Indiana 47802, United States

Kansas City Cancer Centers - Southwest, Overland Park, Kansas 66210, United States

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota 55404, United States

Missouri Cancer Associates, Columbia, Missouri 65201, United States

New York Oncology Hematology, P.C., Hudson, New York 12534, United States

Interlakes Oncology Hematology, PC, Rochester, New York 14623, United States

Cancer Centers of North Carolina, Raleigh, North Carolina 27607, United States

Mahoning Valley Hematology Oncology Associates, Boardman, Ohio 44514, United States

Greater Dayton Cancer Center, Kettering, Ohio 45409, United States

Medical Oncology Associates, Kingston, Pennsylvania 18704, United States

Texas Oncology, P.A. Amarillo, Amarillo, Texas 79106, United States

Texas Cancer Center, Arlington, Texas 76014, United States

Texas Oncology Cancer Center, Austin, Texas 78731, United States

Mamie McFaddin Ward Cancer Center, Beaumont, Texas 77702, United States

Texas Oncology, P.A. - Bedford, Bedford, Texas 76022, United States

Methodist Charlton Cancer Ctr., Dallas, Texas 75237, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230, United States

Texas Oncology, P.A., Dallas, Texas 75231, United States

Texas Oncology, P.A., Dallas, Texas 75246, United States

Texas Cancer Center, Denton, Texas 76210, United States

El Paso Cancer Treatment Ctr, El Paso, Texas 79915, United States

Texas Oncology, P.A., Fort Worth, Texas 76104, United States

Texas Oncology, P.A., Garland, Texas 75042, United States

Lake Vista Cancer Center, Lewisville, Texas 75067, United States

Longview Cancer Center, Longview, Texas 75601, United States

Texas Cancer Center of Mesquite, Mesquite, Texas 75150, United States

Allison Cancer Center, Midland, Texas 79701, United States

Texas Oncology - Odessa, Odessa, Texas 79761, United States

Paris Regional Cancer Center, Paris, Texas 75460, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Texas Oncology Cancer and Research, Waco, Texas 76712, United States

Fairfax Northern VA Hem-Onc PC, Arlington, Virginia 22205, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Onc and Hem Associates of SW VA, Inc., Salem, Virginia 24153, United States

Puget Sound Cancer Center - Edmonds, Edmonds, Washington 98026, United States

Columbia Basin Hematology & Oncology, Kennewicke, Washington 99336, United States

Puget Sound Cancer Center - Seattle, Seattle, Washington 98133, United States

Cancer Care Northwest - South, Spokane, Washington 99202, United States

Northwest Cancer Specialist - Vancouver, Vancouver, Washington 98684, United States

Additional Information

Starting date: July 2007
Last updated: May 19, 2014

Page last updated: August 23, 2015

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