Phase 2
N=150
Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
Gastric Cancer Adenocarcinoma Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT00517829 ↗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
| Outcome | Result | p-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
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.