Clinical trial · Interventional
A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer
An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT02565641CI-TRIAL-00024611completedPhase 2ClinicalTrials.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)
This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine + Gemcitabine
- description
- Participants will receive oral capecitabine (830 milligrams per meter-squared \[mg/m\^2\]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks \[q4w\]) along with IV infusion of gemcitabine (1000 mg/m\^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
- interventionNames
- Drug: Capecitabine
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall objective response rate
- timeFrame
- At the end of 6 cycles (24 weeks)
Secondary outcomes (6)
- measure
- Duration of response
- timeFrame
- Up to approximately 3.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants 18 to 75 years of age * Locally advanced or metastatic pancreatic cancer Exclusion Criteria: \- Prior chemotherapy for pancreatic cancer
References
Publications (0)
Data not yet available
No reference posted for this study.