Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

NCT00517829 | Completed Phase 2 Results

• 1 other identifier: 06063
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 47

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.

Conditions

Gastric Cancer Adenocarcinoma Metastatic

Keywords

metastatic gastric or adenocarcinoma of the GE junction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  Treatment will continue until disease progression or intolerable toxicity

• Objective Response Rate (ORR)

  Treatment will continue until disease progression or intolerable toxicity.

• Time to Response

  Treatment will continue until disease progression or intolerable toxicity

• Duration of Response

  Treatment will continue until disease progression or intolerable toxicity

Study Arms (2)

1- Docetaxel plus Oxaliplatin

ACTIVE COMPARATOR

Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours

Drug: Docetaxel; Drug: oxaliplatin

2- Docetaxel plus oxaliplatin plus cetuximab

ACTIVE COMPARATOR

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; Drug: cetuximab; Drug: oxaliplatin

Interventions

Docetaxel DRUG

Taxotere 60 mg/m2 as an intravenous (IV) infusion over 1 hour

Also known as: Taxotere (docetaxel)

1- Docetaxel plus Oxaliplatin; 2- Docetaxel plus oxaliplatin plus cetuximab

cetuximab DRUG

ERBITUX 400 mg/m2 IV over 120 minutes (first dose only), all other doses are 250 mg/m2 over 60 minutes.

Also known as: ERBITUX (cetuximab)

2- Docetaxel plus oxaliplatin plus cetuximab

oxaliplatin DRUG

Eloxatin 130 mg/m2 IV over 2 hours

Also known as: Eloxatin (oxaliplatin)

1- Docetaxel plus Oxaliplatin; 2- Docetaxel plus oxaliplatin plus cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Eli Lilly and Company: collaborator
• Sanofi: collaborator

Study Sites (47)

Birmingham Hematology and Oncology

Birmingham, Alabama, 35205, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Rocky Mountain Cancer Center - Midtown

Denver, Colorado, 80218, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34655, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Hematology Oncology Associates of Illinois

Chicago, Illinois, 60611, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, 66210, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

New York Oncology Hematology, P.C.

Hudson, New York, 12534, United States

Location

Interlakes Oncology Hematology, PC

Rochester, New York, 14623, United States

Location

Cancer Centers of North Carolina

Raleigh, North Carolina, 27607, United States

Location

Mahoning Valley Hematology Oncology Associates

Boardman, Ohio, 44514, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

Texas Oncology, P.A. Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology, P.A. - Bedford

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75231, United States

Location

Methodist Charlton Cancer Ctr.

Dallas, Texas, 75237, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Cancer Center

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, P.A.

Garland, Texas, 75042, United States

Location

Lake Vista Cancer Center

Lewisville, Texas, 75067, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

Texas Cancer Center of Mesquite

Mesquite, Texas, 75150, United States

Location

Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology - Odessa

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer and Research

Waco, Texas, 76712, United States

Location

Fairfax Northern VA Hem-Onc PC

Arlington, Virginia, 22205, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Onc and Hem Associates of SW VA, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center - Edmonds

Edmonds, Washington, 98026, United States

Location

Columbia Basin Hematology & Oncology

Kennewicke, Washington, 99336, United States

Location

Puget Sound Cancer Center - Seattle

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest - South

Spokane, Washington, 99202, United States

Location

Northwest Cancer Specialist - Vancouver

Vancouver, Washington, 98684, United States

Location

Related Publications (1)

• 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.

  PMID: 23747051 DERIVED

MeSH Terms

Interventions

Docetaxel; Cetuximab; Oxaliplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes

Results Point of Contact

• Title: Dr. Donald Richards
• Organization: Texas Oncology, Tyler Cancer Center

donald.richards@usoncology.com

903-579-9800

Study Officials

• Donald A Richards, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 28, 2016
• Results First Posted: February 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (47)