Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
This study has been completed.
Sponsor:
Cancer Research UK
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032175
First received: March 8, 2002
Last updated: January 13, 2010
Last verified: April 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Survival at 1 year [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life [ Designated as safety issue: No ]
- Median survival rate [ Designated as safety issue: No ]
- Survival rate at 2 years [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Objective response rate [ Designated as safety issue: No ]
| Estimated Enrollment: | 508 |
| Study Start Date: | April 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032175
Locations
| United Kingdom | |
| Royal United Hospital | |
| Bath, England, United Kingdom, BA1 3NG | |
| Royal Bournemouth Hospital | |
| Bournemouth, England, United Kingdom, BH7 7DW | |
| Bristol Haematology and Oncology Centre | |
| Bristol, England, United Kingdom, BS2 8ED | |
| Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Derbyshire Royal Infirmary | |
| Derby, England, United Kingdom, DE1 2QY | |
| Royal Devon and Exeter Hospital | |
| Exeter, England, United Kingdom, EX2 5DW | |
| Ipswich Hospital NHS Trust | |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Queen Elizabeth Hospital | |
| King's Lynn, England, United Kingdom, PE30 4ET | |
| Cookridge Hospital at Leeds Teaching Hospital NHS Trust | |
| Leeds, England, United Kingdom, LS16 6QB | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Lincoln County Hospital | |
| Lincoln, England, United Kingdom, LN2 5QY | |
| Royal Liverpool University Hospital | |
| Liverpool, England, United Kingdom, L69 3GA | |
| Cancer Research UK Liverpool Cancer Trials Unit | |
| Liverpool, England, United Kingdom, L3 9TA | |
| St. Thomas' Hospital | |
| London, England, United Kingdom, SE1 7EH | |
| Christie Hospital NHS Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Clatterbridge Centre for Oncology NHS Trust | |
| Merseyside, England, United Kingdom, CH63 4JY | |
| James Cook University Hospital at South Tees Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Norfolk and Norwich University Hospital | |
| Norwich, England, United Kingdom, NR4 7UY | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Poole Hospital NHS Trust | |
| Poole Dorset, England, United Kingdom, BH15 2JB | |
| Whiston Hospital | |
| Prescot Merseyside, England, United Kingdom, L35 5DR | |
| Royal Preston Hospital | |
| Preston, England, United Kingdom, PR2 9HT | |
| Salisbury District Hospital | |
| Salisbury, England, United Kingdom, SP2 8BJ | |
| Royal South Hants Hospital | |
| Southampton, England, United Kingdom, SO14 0YG | |
| University Hospital of North Staffordshire | |
| Stoke-On-Trent, England, United Kingdom, ST4 7LN | |
| Royal Marsden NHS Foundation Trust - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Warrington Hospital NHS Trust | |
| Warrington, England, United Kingdom, WA5 1QG | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Singleton Hospital of the Swansea NHS Trust | |
| Swansea, Wales, United Kingdom, SA2 8QA | |
Sponsors and Collaborators
Cancer Research UK
Investigators
| Investigator: | Emily Owen | Cancer Research UK |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00032175 History of Changes |
| Other Study ID Numbers: | CDR0000069263, CRUK-GEM-CAP, EU-20116, ISRCTN11513444 |
| Study First Received: | March 8, 2002 |
| Last Updated: | January 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III pancreatic cancer duct cell adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Capecitabine Fluorouracil Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013