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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
capecitabine
gemcitabine hydrochloride
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Royal United Hospital
  • Royal Bournemouth Hospital
  • Bristol Haematology and Oncology Centre
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Derbyshire Royal Infirmary
  • Royal Devon and Exeter Hospital
  • Ipswich Hospital NHS Trust
  • Queen Elizabeth Hospital
  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
  • Leicester Royal Infirmary
  • Lincoln County Hospital
  • Cancer Research UK Liverpool Cancer Trials Unit
  • Royal Liverpool University Hospital
  • St. Thomas' Hospital
  • Christie Hospital NHS Trust
  • Clatterbridge Centre for Oncology NHS Trust
  • James Cook University Hospital at South Tees Hospitals NHS Trust
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Norfolk and Norwich University Hospital
  • Derriford Hospital
  • Poole Hospital NHS Trust
  • Whiston Hospital
  • Royal Preston Hospital
  • Salisbury District Hospital
  • Royal South Hants Hospital
  • University Hospital of North Staffordshire
  • Royal Marsden NHS Foundation Trust - Surrey
  • Warrington Hospital NHS Trust
  • Aberdeen Royal Infirmary
  • Singleton Hospital of the Swansea NHS Trust

Outcomes

Primary Outcome Measures

Survival at 1 year

Secondary Outcome Measures

Quality of life
Median survival rate
Survival rate at 2 years
Toxicity
Objective response rate

Full Information

First Posted
March 8, 2002
Last Updated
June 25, 2013
Sponsor
Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT00032175
Brief Title
Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine. Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens. Compare the toxicity of these regimens in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter. Patients are followed every 3 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
508 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Survival at 1 year
Secondary Outcome Measure Information:
Title
Quality of life
Title
Median survival rate
Title
Survival rate at 2 years
Title
Toxicity
Title
Objective response rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Owen
Organizational Affiliation
Cancer Research UK
Facility Information:
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Ipswich Hospital NHS Trust
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
King's Lynn
State/Province
England
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Facility Name
Cookridge Hospital at Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Cancer Research UK Liverpool Cancer Trials Unit
City
Liverpool
State/Province
England
ZIP/Postal Code
L3 9TA
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L69 3GA
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Christie Hospital NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital at South Tees Hospitals NHS Trust
City
Middlesbrough, Cleveland
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Poole Hospital NHS Trust
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Warrington Hospital NHS Trust
City
Warrington
State/Province
England
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Singleton Hospital of the Swansea NHS Trust
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19858379
Citation
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.
Results Reference
result

Learn more about this trial

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

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