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Pancreatic CancerPhase 3NCT00032175

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

A Phase 3 study testing capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Cancer Research UK at 30 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
capecitabine and gemcitabine hydrochloride
How many people
508 participants
Where
30 sitesUnited Kingdom
Study dates
Apr 2002to May 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United Kingdom30 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Ipswich Hospital NHS Trust

    Ipswich, England, IP4 5PD

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Cookridge Hospital at Leeds Teaching Hospital NHS Trust

    Leeds, England, LS16 6QB

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Cancer Research UK Liverpool Cancer Trials Unit

    Liverpool, England, L3 9TA

  • Royal Liverpool University Hospital

    Liverpool, England, L69 3GA

  • St. Thomas' Hospital

    London, England, SE1 7EH

  • Christie Hospital NHS Trust

    Manchester, England, M20 4BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • James Cook University Hospital at South Tees Hospitals NHS Trust

    Middlesbrough, Cleveland, England, TS4 3BW

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Poole Hospital NHS Trust

    Poole Dorset, England, BH15 2JB

  • Whiston Hospital

    Prescot Merseyside, England, L35 5DR

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Salisbury District Hospital

    Salisbury, England, SP2 8BJ

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital of the Swansea NHS Trust

    Swansea, Wales, SA2 8QA

  • Warrington Hospital NHS Trust

    Warrington, England, WA5 1QG

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Keywords
stage III pancreatic cancer, duct cell adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival at 1 year

Secondary outcomes (5)

  1. Quality of life

  2. Median survival rate

  3. Survival rate at 2 years

  4. Toxicity

  5. Objective response rate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2002
  3. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
508 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00032175
Sponsor's protocol ID
CRUK-GEM-CAP
Other IDs
CDR0000069263, EU-20116, ISRCTN11513444
Status last verified
Apr 2007
First submitted
8 Mar 2002
Last updated
26 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 19858379

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine and gemcitabine hydrochloride in people with Pancreatic Cancer, run by Cancer Research UK at 30 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival at 1 year. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00032175, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.

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