Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT00032175 | Completed Phase 3

• 4 other identifiers: CRUK-GEM-CAPCDR0000069263EU-20116ISRCTN11513444
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 30

Brief Summary

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

Pancreatic Cancer

Keywords

stage III pancreatic cancer; duct cell adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Survival at 1 year

Secondary Outcomes (5)

• Quality of life

• Median survival rate

• Survival rate at 2 years

• Toxicity

• Objective response rate

Interventions

capecitabine DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (30)

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Queen Elizabeth Hospital

Kings Lynn, England, PE30 4ET, United Kingdom

Location

Cookridge Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS16 6QB, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Cancer Research UK Liverpool Cancer Trials Unit

Liverpool, England, L3 9TA, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L69 3GA, United Kingdom

Location

St. Thomas' Hospital

London, England, SE1 7EH, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital at South Tees Hospitals NHS Trust

Middlesbrough, Cleveland, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Poole Hospital NHS Trust

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Singleton Hospital of the Swansea NHS Trust

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (1)

• Cunningham 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 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Emily Owen

  Cancer Research UK

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Study Completion: May 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-04

Locations

GB (30)