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

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.

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: capecitabine [Xeloda]

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 4

Contacts and Locations

Study 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, 105229
  • Moscow, Russian Federation, 107005
  • Moscow, Russian Federation, 119992
  • Moscow, Russian Federation, 123354
  • Moscow, Russian Federation, 127006
  • Moscow, Russian Federation, 143420
  • 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, 634050
  • Tomsk, Russian Federation, 634028
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: capecitabine [Xeloda]; 1250mg/m2 po bid on days 1-14 of each 3 week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE	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.	Up to 25 weeks (from Baseline to the end of safety follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE	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.	Up to 25 weeks (from Baseline to the end of safety follow-up)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 17, 2007
• First Submitted That Met QC Criteria: July 17, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: ML20592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No