Clinical trial · Interventional
Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
NCT00032175CI-TRIAL-00011063completedPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.
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 hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival at 1 year
Secondary outcomes (5)
- measure
- Quality of life
- measure
- Median survival rate
- measure
- Survival rate at 2 years
- measure
- Toxicity
- measure
- Objective response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas * Locally advanced or metastatic disease not amenable to curative surgical resection * Macroscopic residual disease after prior resection with histological confirmation is allowed * Unidimensionally measurable disease * No intracerebral metastases or meningeal carcinomatosis PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * WHO 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm3 * Neutrophil count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin less than 2 mg/dL Renal: * Creatinine less than 2 mg/dL * Creatinine clearance greater than 50 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease * No uncontrolled angina pectoris Other: * No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other concurrent uncontrolled medical condition * No other medical or psychiatric condition that would preclude study * No known hypersensitivity to fluorouracil * No dihydropyrimidine dehydrogenase deficiency * No known malabsorption syndromes * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy (including preoperative or adjuvant) for this disease * No other concurrent cytotoxic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy (including preoperative or adjuvant) for this disease Surgery: * See Disease Characteristics Other: * No prior investigational drugs (including preoperative or adjuvant) for this disease * No other concurrent investigational drugs * No concurrent dipyridamole or allopurinol * No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)
References
Publications (1)
- RESULTCunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. doi: 10.1200/JCO.2009.24.2446. Epub 2009 Oct 26. PMID 19858379