Gastric Cancer Adenocarcinoma Metastatic Clinical Trial
Official title:
Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
| Verified date | January 2016 |
| Source | US Oncology Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Oncology, P.A. Amarillo | Amarillo | Texas |
| United States | Fairfax Northern VA Hem-Onc PC | Arlington | Virginia |
| United States | Texas Cancer Center | Arlington | Texas |
| United States | Texas Oncology Cancer Center | Austin | Texas |
| United States | Mamie McFaddin Ward Cancer Center | Beaumont | Texas |
| United States | Texas Oncology, P.A. - Bedford | Bedford | Texas |
| United States | Birmingham Hematology and Oncology | Birmingham | Alabama |
| United States | Mahoning Valley Hematology Oncology Associates | Boardman | Ohio |
| United States | Hematology Oncology Associates of Illinois | Chicago | Illinois |
| United States | Missouri Cancer Associates | Columbia | Missouri |
| United States | Methodist Charlton Cancer Ctr. | Dallas | Texas |
| United States | Texas Cancer Center at Medical City | Dallas | Texas |
| United States | Texas Oncology, P.A. | Dallas | Texas |
| United States | Texas Oncology, P.A. | Dallas | Texas |
| United States | Texas Cancer Center | Denton | Texas |
| United States | Rocky Mountain Cancer Center - Midtown | Denver | Colorado |
| United States | Puget Sound Cancer Center - Edmonds | Edmonds | Washington |
| United States | El Paso Cancer Treatment Ctr | El Paso | Texas |
| United States | Texas Oncology, P.A. | Fort Worth | Texas |
| United States | Texas Oncology, P.A. | Garland | Texas |
| United States | New York Oncology Hematology, P.C. | Hudson | New York |
| United States | Central Indiana Cancer Centers | Indianapolis | Indiana |
| United States | Columbia Basin Hematology & Oncology | Kennewicke | Washington |
| United States | Greater Dayton Cancer Center | Kettering | Ohio |
| United States | Medical Oncology Associates | Kingston | Pennsylvania |
| United States | Lake Vista Cancer Center | Lewisville | Texas |
| United States | Longview Cancer Center | Longview | Texas |
| United States | Texas Cancer Center of Mesquite | Mesquite | Texas |
| United States | Allison Cancer Center | Midland | Texas |
| United States | Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota |
| United States | Florida Cancer Institute | New Port Richey | Florida |
| United States | Cancer Care & Hematology Specialists of Chicagoland | Niles | Illinois |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Ocala Oncology Center | Ocala | Florida |
| United States | Texas Oncology - Odessa | Odessa | Texas |
| United States | Kansas City Cancer Centers - Southwest | Overland Park | Kansas |
| United States | Paris Regional Cancer Center | Paris | Texas |
| United States | Hematology Oncology Associates | Phoenix | Arizona |
| United States | Cancer Centers of North Carolina | Raleigh | North Carolina |
| United States | Interlakes Oncology Hematology, PC | Rochester | New York |
| United States | Onc and Hem Associates of SW VA, Inc. | Salem | Virginia |
| United States | Puget Sound Cancer Center - Seattle | Seattle | Washington |
| United States | Cancer Care Northwest - South | Spokane | Washington |
| United States | Hope Center | Terre Haute | Indiana |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Northwest Cancer Specialist - Vancouver | Vancouver | Washington |
| United States | Texas Oncology Cancer and Research | Waco | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| US Oncology Research | ImClone LLC, Sanofi |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Treatment will continue until disease progression or intolerable toxicity | No |
| Secondary | 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 | No |
| Secondary | Objective Response Rate (ORR) | Complete response (CR) + Partial Response (PR) | Treatment will continue until disease progression or intolerable toxicity. | No |
| Secondary | 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 | No |
| Secondary | 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 | No |