NCT00030732

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P50-P75 for phase_3 pancreatic-cancer

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_3 pancreatic-cancer

Geographic Reach
4 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

February 14, 2002

Last Update Submit

May 14, 2019

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancerrecurrent pancreatic canceradenocarcinoma of the pancreasstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (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.

    8 weeks

Study Arms (2)

Gemcitabine + Capecitabine

ACTIVE COMPARATOR

Gemcitabine + Capecitabine

Drug: Gemcitabine + Capecitabine

Gemcitabine alone

ACTIVE COMPARATOR

Gemcitabine alone

Drug: Gemcitabine alone

Interventions

Gemcitabine + CapecitabineDRUG

Gemcitabine + Capecitabine

Gemcitabine + Capecitabine
Gemcitabine aloneDRUG

Gemcitabine alone

Gemcitabine alone

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (18)

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitatsspital-Basel

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Ratisches Kantons und Regionalspital

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Institut Central des Hopitaux Valaisans

Sion, CH1951, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Oncology Institute of Southern Switzerland

Zurich, CH-8091, Switzerland

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 20877359RESULT

  • 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.

    PMID: 18669454RESULT

  • 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.

    PMID: 18249033RESULT

  • 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.

    PMID: 17538165RESULT

  • 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.

    PMID: 30636977RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Richard Herrmann, MD

    Universitaetsspital-Basel

    STUDY CHAIR

  • Werner Scheithauer, MD

    Allgemeines Krankenhaus - Universitatskliniken

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

June 1, 2001

Primary Completion

June 1, 2004

Study Completion

April 1, 2008

Last Updated

May 15, 2019

Record last verified: 2019-05

Locations

AU(1)IL(1)CH(14)IT(2)