Clinical trial · Interventional
Docetaxel and Oxaliplatin in Gastric Cancer
A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
- 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)
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective: * To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives: * To establish the safety profile. * To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria * To assess the Overall Survival (OS)
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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel + Oxaliplatin | Drug | — | UNRESOLVED |
| Docetaxel + Oxaliplatin + 5-FU | Drug | — | UNRESOLVED |
| Docetaxel + Oxaliplatin + Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- TE (Taxotere and Eloxatin)
- description
- Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study.
- interventionNames
- Drug: Docetaxel + Oxaliplatin
- type
- EXPERIMENTAL
- label
- TEF (Taxotere, Eloxatin and 5-FU)
- description
- Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study.
- interventionNames
- Drug: Docetaxel + Oxaliplatin + 5-FU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically proven gastric adenocarcinoma, including adenocarcinoma of the gastro-oesophageal junction * Metastatic or locally recurrent disease * Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin, epirubicin is allowed provided that the patient has relapsed \> 12 months after the end of the chemotherapy * Performance status Karnofsky index \> 70 * Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil Count ≥2.0 10\^9/L, platelets ≥100 x 10\^9/L * Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT) ≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT \> 1.5 x UNL is not associated with alkaline phosphatase \> 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL \< creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min) * Measurable and/or evaluable metastatic disease Exclusion criteria: * Any prior palliative chemotherapy * Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse Events grade≥2 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (1)
- DERIVEDVan Cutsem E, Boni C, Tabernero J, Massuti B, Middleton G, Dane F, Reichardt P, Pimentel FL, Cohn A, Follana P, Clemens M, Zaniboni A, Moiseyenko V, Harrison M, Richards DA, Prenen H, Pernot S, Ecstein-Fraisse E, Hitier S, Rougier P. Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study. Ann Oncol. 2015 Jan;26(1):149-156. doi: 10.1093/annonc/mdu496. PMID 25416687