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Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Gastric or GEJ Cancer

Thank you

Trial Information

Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Treatment will continue until disease progression or intolerable toxicity

Safety Issue:

No

Principal Investigator

Donald A Richards, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Institutional Review Board

Study ID:

06063

NCT ID:

NCT00517829

Start Date:

July 2007

Completion Date:

September 2011

Related Keywords:

  • Metastatic Gastric or GEJ Cancer

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Ocala Oncology CenterOcala, Florida  34474
Missouri Cancer AssociatesColumbia, Missouri  65201
Tyler Cancer CenterTyler, Texas  75702
Hope CenterTerre Haute, Indiana  47809
New York Oncology Hematology, P.C.Albany, New York  12208
Hematology Oncology Associates of IllinoisSkokie, Illinois  60077
Medical Oncology AssociatesKingston, Pennsylvania  18704
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
Hematology Oncology AssociatesPhoenix, Arizona  85012
Greater Dayton Cancer CenterKettering, Ohio  45409
Birmingham Hematology and OncologyBirmingham, Alabama  35235
Rocky Mountain Cancer Center - MidtownDenver, Colorado  80218
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Onc and Hem Associates of SW VA, Inc.Salem, Virginia  24153
Puget Sound Cancer Center - EdmondsEdmonds, Washington  98026
Paris Regional Cancer CenterParis, Texas  75460
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Interlakes Oncology Hematology, PCRochester, New York  14623
Texas Oncology, P.A. - BedfordBedford, Texas  76022
El Paso Cancer Treatment CtrEl Paso, Texas  79915
Fairfax Northern VA Hem-Onc PCFairfax, Virginia  22031
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Methodist Charlton Cancer Ctr.Dallas, Texas  75237
Mahoning Valley Hematology Oncology AssociatesBoardman, Ohio  44514
Texas Oncology - OdessaOdessa, Texas  79761
Texas Oncology, P.A. AmarilloAmarillo, Texas  79106
Texas Oncology Cancer and ResearchWaco, Texas  76712
Columbia Basin Hematology & OncologyKennewicke, Washington  99336
Puget Sound Cancer Center - SeattleSeattle, Washington  98133
Cancer Care Northwest - SouthSpokane, Washington  99202
Northwest Cancer Specialist - VancouverVancouver, Washington  98684