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

NCT00425360 | Completed Phase 3

• 5 other identifiers: CDR0000528021CRUK-TELOVAC-V4EUDRACT-2006-000461-10EU-20683ISRTCN43482138
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 45

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival at 1 year

Secondary Outcomes (6)

• Time to progression

• Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life (QLQ) C30 questionnaire and the European Study group for Pancreatic Cancer-QLQ questionnaire

• Clinical benefit response

• Objective response rate as assessed by RECIST criteria

• Toxicity as assessed by NCI CTCAE version 3

Interventions

sargramostim BIOLOGICAL

telomerase peptide vaccine GV1001 BIOLOGICAL

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 pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas * Locally advanced or metastatic disease precluding curative surgical resection * Unidimensionally measurable disease by CT scan * No intracerebral metastases or meningeal carcinomatosis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * WBC \> 3,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Bilirubin \< 2.0 mg/dL * Creatinine clearance \> 50 mL/min * No medical or psychiatric condition that would preclude giving informed consent * No clinically significant serious disease or organ system disease not currently controlled on present therapy * No uncontrolled angina pectoris * Not pregnant or nursing * Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment * No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No known malabsorption syndrome * No known hypersensitivity to any of the investigational agents * No dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No radiotherapy within the past 4 weeks * No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition) * Concurrent short-term steroids for palliation of cancer-related symptoms allowed * No other concurrent investigational drugs or cytotoxic agents * No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001 * Concurrent low-dose corticosteroids may be allowed

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

Sponsors & Collaborators

• Royal Liverpool University Hospital: lead

Study Sites (45)

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Pilgrim Hospital

Boston, England, PE21 9QT, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 0QQ, United Kingdom

Location

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Cancer Research UK Clinical Groups at Guy's King's & St. Thomas' Hospitals

London, England, SE5 9NU, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

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

Location

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LJ, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

sargramostim; 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

• Gary W. Middleton

  St. Luke's Cancer Centre at Royal Surrey County Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: September 1, 2006
• Study Completion: March 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2009-05

Locations

GB (45)