A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502671
First received: July 17, 2007
Last updated: May 7, 2013
Last verified: May 2013
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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:
- SAEs, AEs, laboratory parameters. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 228 |
| Study Start Date: | July 2007 |
| Study Completion Date: | November 2012 |
| 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 |
| 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
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 | |
| Izhevsk, Russian Federation, 426009 | |
| Kaluga, Russian Federation, 248007 | |
| Kazan, Russian Federation, 420111 | |
| Kazan, Russian Federation, 420029 | |
| Kirov, Russian Federation, 610021 | |
| Kostroma, Russian Federation, 156005 | |
| Krasnodar, Russian Federation, 350080 | |
| Kursk, Russian Federation, 305035 | |
| Lipetsk, Russian Federation, 398005 | |
| Moscow, Russian Federation, 105229 | |
| Moscow, Russian Federation, 107005 | |
| Moscow, Russian Federation, 119992 | |
| Moscow, Russian Federation, 127006 | |
| Moscow, Russian Federation, 143420 | |
| Moscow, Russian Federation, 123354 | |
| 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, 443066 | |
| 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
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00502671 History of Changes |
| Other Study ID Numbers: | ML20592 |
| Study First Received: | July 17, 2007 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Russia: Ministry of Health |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal 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 Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013