Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

US Oncology Network

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer Adenocarcinoma Metastatic

Treatments: Drug: oxaliplatin; Drug: cetuximab; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517829

06063

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1- Docetaxel plus Oxaliplatin

Active Comparator group

Description:

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

Treatment:

Drug: Docetaxel

Drug: oxaliplatin

2- Docetaxel plus oxaliplatin plus cetuximab

Active Comparator group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: oxaliplatin

Drug: cetuximab