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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032175
• Other study ID #: CRUK-GEM-CAP
• Secondary ID: CDR0000069263EU-
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2002
• Last updated: June 25, 2013
• Start date: April 2002
• Est. completion date: May 2007

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• capecitabine

• gemcitabine hydrochloride

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Queen Elizabeth Hospital	King's Lynn	England
United Kingdom	Cookridge Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Cancer Research UK Liverpool Cancer Trials Unit	Liverpool	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	St. Thomas' Hospital	London	England
United Kingdom	Christie Hospital NHS Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	James Cook University Hospital at South Tees Hospitals NHS Trust	Middlesbrough, Cleveland	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Poole Hospital NHS Trust	Poole Dorset	England
United Kingdom	Whiston Hospital	Prescot Merseyside	England
United Kingdom	Royal Preston Hospital	Preston	England
United Kingdom	Salisbury District Hospital	Salisbury	England
United Kingdom	Royal South Hants Hospital	Southampton	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Singleton Hospital of the Swansea NHS Trust	Swansea	Wales
United Kingdom	Warrington Hospital NHS Trust	Warrington	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

References & 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 1 year			No
Secondary	Quality of life			No
Secondary	Median survival rate			No
Secondary	Survival rate at 2 years			No
Secondary	Toxicity			Yes
Secondary	Objective response rate			No