Phase 2
N=254
Docetaxel and Oxaliplatin in Gastric Cancer
Stomach Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00382720 ↗Enrolled (actual)
254
Serious AEs
38.3%
Results posted
Aug 2011
Primary outcome: Primary: Time to Progression — 4.50; 7.66; 5.55 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Docetaxel + Oxaliplatin (Drug); Docetaxel + Oxaliplatin + 5-FU (Drug); Docetaxel + Oxaliplatin + Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
4.50; 7.66; 5.55 | — |
| SECONDARY Best Overall Response Rate (ORR) |
23.1; 46.6; 25.6 | — |
| SECONDARY Overall Survival (OS) |
8.97; 14.59; 11.30 | — |
Summary
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)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00382720). 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.