Clinical trial · Interventional
Docetaxel and Capecitabine in Advanced Gastric Cancer
Phase II Study of Docetaxel and Capecitabine as 1st Line Therapy for Patients With Locally Advanced or Metastatic Gastric Cancer
- 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)
Up to date there is no worldwide accepted standard chemotherapy for the 1st-line treatment of advanced or metastatic gastric cancer.A combination of epirubicin, cisplatin and 5-FU (ECF) is the best examined combination and widely used. Recent studies (Thuss-Patience et al, J. Clin. Oncol. 2005) could show that a combination of docetaxel and 5-FU might be similarly effective as ECF. 5-FU and docetaxel +/- cisplatin combinations are investigated by many groups and may be a future reference treatment. Many data suggest that 5-FU infusion can be replaced by oral capecitabine with equal efficacy. As docetaxel/5-FU is probably similarly effective as epirubicin/cisplatin/5-FU and a replacement of 5-FU infusion by capecitabine makes the chemotherapy more comfortable for the patient we investigate in this study a chemotherapy of docetaxel and capecitabine as 1st-line therapy for metastatic or advanced gastric cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response Rate
Secondary outcomes (4)
- measure
- Median Survival
- measure
- Time to Tumor Progression
- measure
- Toxicity
- measure
- Quality of Life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven adenocarcinoma of the stomach or the GE-junction. * Patients with distant metastases or patients with locally advanced disease who are not curatively operable proven by laparoscopy or patients with a recurrence after gastrectomy. * Patients who did not receive any prior palliative chemotherapy. An adjuvant chemotherapy is allowed. * Age between 18 and 75 years. * Sufficient bone marrow function defined as leucocytes \> 3.0 Gpt/l, thrombocytes \> 100 Gpt/l * Sufficient liver function defined as bilirubin \< 1.5 mg/dl (1.5 x ULN), ALT and AST \< 3 x ULN. * Sufficient renal function defined as serum creatinine \< 1.25 x ULN, or creatinine clearance \> 60 ml/min calculated according to Cockroft-Gault * Contraception in patients with reproductive potential. * Karnofsky-performance-index at least 60% * Measurable tumor lesions. * Written informed consent of the patient. Exclusion Criteria: * Karnofsky-performance-index less or equal 50%. * Patients who already received a palliative first-line chemotherapy. * Prior second malignancy, except basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix. * Parallel radiation therapy * Uncontrolled infection. * CNS-metastasis * Other severe medical disease * Prior major surgery for less than 2 weeks * Parallel treatment with other experimental therapies. * Parallel treatment with any other therapy aiming against the tumor. * Chronic diarrhea, subileus. * Chronic inflammatory bowel disease or intestinal obstruction. * Unable to take oral medication. * Pregnancy or breast feeding.
References
Publications (1)
- BACKGROUNDThuss-Patience PC, Kretzschmar A, Repp M, Kingreen D, Hennesser D, Micheel S, Pink D, Scholz C, Dorken B, Reichardt P. Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol. 2005 Jan 20;23(3):494-501. doi: 10.1200/JCO.2005.02.163. PMID 15659494