Clinical trial · Interventional
Docetaxel+Oxali+/-Cetux Met Gastric/GEJ
Phase II Trial of Docetaxel Plus Oxaliplatin (DOCOX) With or Without Cetuximab in Patients With Metastatic Gastric and/or Gastroesophageal Junction Adenocarcinoma
NCT00517829CI-TRIAL-00024911completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Adenocarcinoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cetuximab | Drug | Cetuximab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1- Docetaxel plus Oxaliplatin
- description
- Docetaxel as an intravenous (IV) infusion over 1 hour, followed by oxaliplatin IV over 2 hours
- interventionNames
- Drug: Docetaxel
- Drug: oxaliplatin
- type
- ACTIVE_COMPARATOR
- label
- 2- Docetaxel plus oxaliplatin plus cetuximab
- 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.
- interventionNames
- Drug: Docetaxel
- Drug: cetuximab
- Drug: oxaliplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRichards D, Kocs DM, Spira AI, David McCollum A, Diab S, Hecker LI, Cohn A, Zhan F, Asmar L. Results of docetaxel plus oxaliplatin (DOCOX) +/- cetuximab in patients with metastatic gastric and/or gastroesophageal junction adenocarcinoma: results of a randomised Phase 2 study. Eur J Cancer. 2013 Sep;49(13):2823-31. doi: 10.1016/j.ejca.2013.04.022. Epub 2013 Jun 5. PMID 23747051