Clinical trial · Interventional
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
NCT00030732CI-TRIAL-00038625completedPhase 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 determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced 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 |
|---|---|---|---|
| Gemcitabine alone | Drug | — | UNRESOLVED |
| Gemcitabine + Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine + Capecitabine
- description
- Gemcitabine + Capecitabine
- interventionNames
- Drug: Gemcitabine + Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine alone
- description
- Gemcitabine alone
- interventionNames
- Drug: Gemcitabine alone
Primary outcomes (1)
- measure
- Gemcitabine + Capecitabine vs. Gemcitabine alone
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma * No CNS metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic: * Bilirubin no greater than 5 times normal * AST/ALT no greater than 5 times normal * Alkaline phosphatase no greater than 5 times normal Renal: * Creatinine clearance at least 30 mL/min Gastrointestinal: * No grade 2 or greater nausea or grade 1 or greater vomiting * No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction) Other: * No prior unanticipated severe reaction to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No active infection * No other serious concurrent systemic disorders that would preclude study participation * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior capecitabine * No prior chemotherapy for advanced pancreatic cancer * At least 1 year since prior radiochemotherapy for pancreatic cancer Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy * At least 1 year since prior adjuvant radiotherapy for pancreatic cancer * No concurrent radiotherapy Surgery: * Prior Whipple procedure or duodenal bypass allowed Other: * At least 1 month since prior investigational agents * No concurrent sorivudine or its chemically related analogues (e.g., brivudine) * No other concurrent anticancer or investigational drugs
References
Publications (5)
- RESULTBernhard J, Dietrich D, Glimelius B, Hess V, Bodoky G, Scheithauer W, Herrmann R. Estimating prognosis and palliation based on tumour marker CA 19-9 and quality of life indicators in patients with advanced pancreatic cancer receiving chemotherapy. Br J Cancer. 2010 Oct 26;103(9):1318-24. doi: 10.1038/sj.bjc.6605929. Epub 2010 Sep 28. PMID 20877359
- RESULTBernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. doi: 10.1200/JCO.2007.15.6240. PMID 18669454
- RESULTHess V, Glimelius B, Grawe P, Dietrich D, Bodoky G, Ruhstaller T, Bajetta E, Saletti P, Figer A, Scheithauer W, Herrmann R. CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial. Lancet Oncol. 2008 Feb;9(2):132-8. doi: 10.1016/S1470-2045(08)70001-9. PMID 18249033
- RESULTHerrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. doi: 10.1200/JCO.2006.09.0886. PMID 17538165
- RESULTGargiulo P, Dietrich D, Herrmann R, Bodoky G, Ruhstaller T, Scheithauer W, Glimelius B, Berardi S, Pignata S, Brauchli P. Predicting mortality and adverse events in patients with advanced pancreatic cancer treated with palliative gemcitabine-based chemotherapy in a multicentre phase III randomized clinical trial: the APC-SAKK risk scores. Ther Adv Med Oncol. 2019 Jan 2;11:1758835918818351. doi: 10.1177/1758835918818351. eCollection 2019.