NCT00658593 is a Phase 3 clinical trial of capecitabine in Extrahepatic Bile Duct Cancer, sponsored by NCIC Clinical Trials Group.

Who is sponsoring NCT00658593?

NCT00658593 is sponsored by NCIC Clinical Trials Group.

What drugs are being tested in NCT00658593?

Interventions in NCT00658593: capecitabine, gemcitabine hydrochloride, quality-of-life assessment.

What condition does NCT00658593 study?

NCT00658593 studies Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer.

Is NCT00658593 still recruiting?

NCT00658593 is currently terminated. Last updated 4 August 2023.

Last reviewed 2023-08-04 · How we verify

NCT00658593

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer

Terminated Phase 3 Last updated 4 August 2023

What this trial tests

Phase 3 trial testing capecitabine in Extrahepatic Bile Duct Cancer in 19 participants. Terminated before completion.

Timeline

10 October 2008

Primary endpoint
11 May 2010

18 January 2011

Quick facts

Lead sponsor	NCIC Clinical Trials Group
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	10 October 2008
Primary completion	11 May 2010
Estimated completion	18 January 2011
Sites	8 locations across Canada

Drugs / interventions tested

capecitabine (capecitabine) — full drug profile →
gemcitabine hydrochloride — full drug profile →
quality-of-life assessment

Conditions studied

Extrahepatic Bile Duct Cancer — all drugs for Extrahepatic Bile Duct Cancer →
Gallbladder Cancer — all drugs for Gallbladder Cancer →
Liver Cancer — all drugs for Liver Cancer →

Sponsor

NCIC Clinical Trials Group

Who can join

Adults 18 to 120, any sex, with Extrahepatic Bile Duct Cancer or Gallbladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether gemcitabine is more effective when given together with or without capecitabine in treating patients with biliary cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with capecitabine to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced, unresectable, or metastatic biliary cancer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Current status of chemotherapy for the treatment of advanced biliary tract cancer.
Sasaki T, Isayama H, Nakai Y, Koike K. · · 2013 · cited 24× · PMID 24009445 · DOI 10.3904/kjim.2013.28.5.515
Identification of active chemotherapy regimens in advanced biliary tract carcinoma: a review of chemotherapy trials in the past two decades.
Ulahannan SV, Rahma OE, Duffy AG, Makarova-Rusher OV, et al · · 2015 · cited 8× · PMID 25685318 · DOI 10.2217/hep.14.36

Verify or expand the search:

Other trials of capecitabine

Trials testing the same drug.

NCT07303283 — Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma · Phase 2 · not yet recruiting
NCT07177794 — Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC · Phase 3 · not yet recruiting
NCT06685289 — Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recur · Phase 2 · recruiting
NCT06802666 — Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer · Phase 2 · recruiting
NCT06607276 — Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE · Phase 2 · recruiting

Other recruiting trials for Extrahepatic Bile Duct Cancer

Currently open trials in the same condition.

NCT02293954 — Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer · NA · active not recruiting

Other NCIC Clinical Trials Group trials

Trials by the same sponsor.

NCT01916187 — Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma · Phase 1 · withdrawn
NCT01830621 — BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma · Phase 3 · completed
NCT01652144 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed Mantle Cell Lymphoma · Phase 2 · completed
NCT01627054 — A Phase II Study of AT7519M, a CDK Inhibitor, in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia · Phase 2 · completed
NCT01486368 — A Phase II Study of PF-03446962 in Patients With Advanced Malignant Pleural Mesothelioma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00658593 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NCIC Clinical Trials Group
Last refreshed: 4 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00658593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing