A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
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| ClinicalTrials.gov Identifier: NCT00502671 |
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Recruitment Status :
Completed
First Posted : July 18, 2007
Results First Posted : September 3, 2015
Last Update Posted : September 3, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: capecitabine [Xeloda] | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 228 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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. |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | March 2012 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Capecitabine
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle |
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) ]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) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 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, 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 |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00502671 |
| Other Study ID Numbers: |
ML20592 |
| First Posted: | July 18, 2007 Key Record Dates |
| Results First Posted: | September 3, 2015 |
| Last Update Posted: | September 3, 2015 |
| Last Verified: | August 2015 |
Additional relevant MeSH terms:
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Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Capecitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |