Mode
Text Size
Log in / Sign up
Phase 2 N=150 Randomized Treatment

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Gastric Cancer Adenocarcinoma Metastatic

Enrolled (actual)
150
Serious AEs
32.9%
Results posted
Feb 2016
Primary outcome: Primary: Progression-free Survival — 4.7; 5.1 months

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Docetaxel (Drug); cetuximab (Drug); oxaliplatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
US Oncology Research
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival
4.7; 5.1
SECONDARY
Overall Survival
8.5; 9.4
SECONDARY
Objective Response Rate (ORR)
26.5; 38.0
SECONDARY
Time to Response
1.3; 1.4
SECONDARY
Duration of Response
7.3; 5.6

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00517829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search