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Pancreatic CancerPhase 3NCT00030732

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

A Phase 3 study testing Gemcitabine + Capecitabine and Gemcitabine alone in people with Pancreatic Cancer, run by Swiss Cancer Institute at 18 sites in 4 countries.

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 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine + Capecitabine and Gemcitabine alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
18 sitesin 4 countries
Study dates
Jun 2001to Apr 2008
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 5 times normal
  • AST/ALT no greater than 5 times normal
  • Alkaline phosphatase no greater than 5 times normal

Renal:

  • Creatinine clearance at least 30 mL/min

Gastrointestinal:

  • No grade 2 or greater nausea or grade 1 or greater vomiting
  • No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction)

Other:

  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No known hypersensitivity to fluorouracil
  • No known dihydropyrimidine dehydrogenase deficiency
  • No active infection
  • No other serious concurrent systemic disorders that would preclude study participation
  • No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior capecitabine
  • No prior chemotherapy for advanced pancreatic cancer
  • At least 1 year since prior radiochemotherapy for pancreatic cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Chemotherapy
  • At least 1 year since prior adjuvant radiotherapy for pancreatic cancer
  • No concurrent radiotherapy

Surgery:

  • Prior Whipple procedure or duodenal bypass allowed

Other:

  • At least 1 month since prior investigational agents
  • No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
  • No other concurrent anticancer or investigational drugs

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

Switzerland14 sites

  • Kantonspital Aarau

    Aarau, 5001

  • Saint Claraspital AG

    Basel, CH-4016

  • Universitatsspital-Basel

    Basel, CH-4031

  • Inselspital, Bern

    Bern, CH-3010

  • Spitalzentrum Biel

    Biel, CH-2501

  • Ratisches Kantons und Regionalspital

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Institut Central des Hopitaux Valaisans

    Sion, CH1951

  • Regionalspital

    Thun, 3600

  • City Hospital Triemli

    Zurich, 8063

  • Oncology Institute of Southern Switzerland

    Zurich, CH-8091

  • UniversitaetsSpital

    Zurich, CH-8091

Other trials in Switzerland

Italy2 sites

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milan, 20133

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

Other trials in Italy

Austria1 site

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, A-1090

Other trials in Austria

Israel1 site

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

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 determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
  • Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in 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 a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.

Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Being tested
Gemcitabine + Capecitabine, Gemcitabine alone
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, 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.

  • Gemcitabine + CapecitabineDrug

    Gemcitabine + Capecitabine

  • Gemcitabine aloneDrug

    Gemcitabine alone

Study groups in NCT00030732
Study groupRoleWhat they receive
Gemcitabine + CapecitabineActive comparatorGemcitabine + Capecitabine
Receives: Drug: Gemcitabine + Capecitabine
Gemcitabine aloneActive comparatorGemcitabine alone
Receives: Drug: Gemcitabine alone

What is being measured

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

  1. Gemcitabine + Capecitabine vs. Gemcitabine alone

    To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.

    Measured: 8 weeks

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 startJun 2001
  3. Primary completionJun 2004
  4. Study completionApr 2008

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
Intervention model
Factorial
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030732
Sponsor's protocol ID
SAKK 44/00
Other IDs
SWS-SAKK-44/00, CECOG/PAN-1.3.001, EU-20142
Status last verified
May 2019
First submitted
14 Feb 2002
Last updated
15 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Bernhard J, Dietrich D, Glimelius B, Hess V, Bodoky G, Scheithauer W, Herrmann R. Estimating prognosis and palliation based on tumour marker CA 19-9 and quality of life indicators in patients with advanced pancreatic cancer receiving chemotherapy. Br J Cancer. 2010 Oct 26;103(9):1318-24. doi: 10.1038/sj.bjc.6605929. Epub 2010 Sep 28.

    PubMed 20877359

  • Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. doi: 10.1200/JCO.2007.15.6240.

    PubMed 18669454

  • Hess V, Glimelius B, Grawe P, Dietrich D, Bodoky G, Ruhstaller T, Bajetta E, Saletti P, Figer A, Scheithauer W, Herrmann R. CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial. Lancet Oncol. 2008 Feb;9(2):132-8. doi: 10.1016/S1470-2045(08)70001-9.

    PubMed 18249033

  • Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. doi: 10.1200/JCO.2006.09.0886.

    PubMed 17538165

  • Gargiulo P, Dietrich D, Herrmann R, Bodoky G, Ruhstaller T, Scheithauer W, Glimelius B, Berardi S, Pignata S, Brauchli P. Predicting mortality and adverse events in patients with advanced pancreatic cancer treated with palliative gemcitabine-based chemotherapy in a multicentre phase III randomized clinical trial: the APC-SAKK risk scores. Ther Adv Med Oncol. 2019 Jan 2;11:1758835918818351. doi: 10.1177/1758835918818351. eCollection 2019.

    PubMed 30636977

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine + Capecitabine and Gemcitabine alone in people with Pancreatic Cancer, run by Swiss Cancer Institute at 18 sites in 4 countries.

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 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Switzerland, Italy, Austria, Israel. 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?

Gemcitabine + Capecitabine vs. Gemcitabine alone (time frame: 8 weeks). 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 NCT00030732, which also lists 5 linked publications.

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 15 May 2019.

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