A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502671
First received: July 17, 2007
Last updated: August 6, 2015
Last verified: August 2015
  Purpose
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine [Xeloda]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ] [ Designated as safety issue: No ]
    The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.


Secondary Outcome Measures:
  • Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ] [ Designated as safety issue: No ]
    The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.


Enrollment: 228
Study Start Date: July 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • colon cancer (Dukes stage C);
  • surgery, with no evidence of remaining tumor;
  • ECOG performance status of <=1.

Exclusion Criteria:

  • previous therapy for currently treated colon cancer;
  • any evidence of metastatic disease;
  • history of other malignancy within last 5 years;
  • clinically significant cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502671

Locations
Russian Federation
Arkhangelsk, Russian Federation, 163045
Astrakhan, Russian Federation, 414041
Barnaul, Russian Federation, 656049
Belgorod, Russian Federation, 308010
Chelyabinsk, Russian Federation, 454047
Ekaterinburg, Russian Federation, 620905
Irkutsk, Russian Federation, 664035
Izhevsk, Russian Federation, 426009
Kaluga, Russian Federation, 248007
Kazan, Russian Federation, 420029
Kazan, Russian Federation, 420111
Kirov, Russian Federation, 610021
Kostroma, Russian Federation, 156005
Krasnodar, Russian Federation, 350040
Kursk, Russian Federation, 305035
Lipetsk, Russian Federation, 398005
Moscow, Russian Federation, 127006
Moscow, Russian Federation, 107005
Moscow, Russian Federation, 119992
Moscow, Russian Federation, 123354
Moscow, Russian Federation, 143420
Moscow, Russian Federation, 105229
Nizhny Novgorod, Russian Federation, 603126
Novgorod Veliky, Russian Federation, 173016
Obninsk, Russian Federation, 249036
Orenburg, Russian Federation, 460021
Perm, Russian Federation, 614 066
Rostov-na-donu, Russian Federation, 344037
Ryazan, Russian Federation, 390011
Salekhard, Russian Federation, 629001
Samara, Russian Federation, 443031
Smolensk, Russian Federation, 214000
Soshi, Russian Federation, 354057
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 197047
Stavropol, Russian Federation, 355047
Surgut, Russian Federation, 628408
Tollyatti, Russian Federation, 445846
Tomsk, Russian Federation, 634028
Tomsk, Russian Federation, 634050
Tumen, Russian Federation, 625047
Tver, Russian Federation, 170008
UFA, Russian Federation, 450005
UFA, Russian Federation, 450054
Volgograd, Russian Federation, 400138
Yuzhno-Sakhalinsk, Russian Federation, 693010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502671     History of Changes
Other Study ID Numbers: ML20592 
Study First Received: July 17, 2007
Results First Received: August 6, 2015
Last Updated: August 6, 2015
Health Authority: Russia: Ministry of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 25, 2016