Clinical trial · Interventional
Dose Escalation Study of Liposomal Paclitaxel With/Without Capecitabine in Patients With Advanced Gastric Carcinoma
A Phase I Clinical Trial to Investigate the Maximum Tolerated Dose and Pharmacokinetics of Liposomal Paclitaxel With/Without Capecitabine in Chinese Cancer Patients With Advanced Gastric Carcinoma.
NCT00639522CI-TRIAL-00002215unknownPhase 1ClinicalTrials.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 study is to investigate the maximum tolerated dose and pharmacokinetics of liposomal paclitaxel with/without capecitabine in Chinese cancer patients with advanced gastric carcinoma.
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 Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal paclitaxel and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Liposomal paclitaxel and capecitabine
Primary outcomes (1)
- measure
- Dose limiting toxicity
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- Pharmacokinetics
- timeFrame
- 48 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified gastric carcinoma of advanced stages which is unsuitable for surgery; * No prior systemic chemotherapy with taxane at least 6 months before the recruitment; * At least one measurable tumor according to RECIST standard, with at least one diameter ≥20mm assessed by traditional imaging technique or MRI, or with a diameter twice of the thickness of scan layer (or ≥10-16mm) under spiral CT; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; * Patients who are expected to live at least 3 months; * Obtaining informed consent; Exclusion Criteria: * Receiving other chemotherapy or radiotherapy during the administration; * Symptomatic metastatic brain tumor; * Allergy to any study medication; * Pregnancy or breast feeding; * Severe heart diseases; * Uncontrolled mental diseases; * Abnormal liver and renal functions, which are measured by AST/ALT and BUN/Cr; * Neutrophils(ANC)\<2000/μL;platelets\<100,000/μL;hemoglobin(HB)\<9.0 g/dL;
References
Publications (0)
Data not yet available
No reference posted for this study.