Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer. (NCT NCT00502671)
NCT ID: NCT00502671
Last Updated: 2015-09-03
Results Overview
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.
COMPLETED
PHASE4
228 participants
Up to 25 weeks (from Baseline to the end of safety follow-up)
2015-09-03
Participant Flow
Participant milestones
| Measure |
Capecitabine
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m\^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
228
|
|
Overall Study
COMPLETED
|
151
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Capecitabine
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m\^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Overall Study
Disease Progression
|
13
|
|
Overall Study
Personal Reasons
|
22
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Protocol Violation
|
16
|
|
Overall Study
Adverse Event
|
19
|
Baseline Characteristics
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
Baseline characteristics by cohort
| Measure |
Capecitabine
n=228 Participants
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 25 weeks (from Baseline to the end of safety follow-up)Population: Safety Population.
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.
Outcome measures
| Measure |
Capecitabine
n=228 Participants
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Any AE
|
56.1 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Serious AE
|
6.1 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
Death due to an AE
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 25 weeks (from Baseline to the end of safety follow-up)Population: Safety Population.
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.
Outcome measures
| Measure |
Capecitabine
n=228 Participants
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Early withdrawal due to an AE
|
8.3 percentage of participants
|
|
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
Discontinuation due to an AE
|
10.1 percentage of participants
|
Adverse Events
Capecitabine
Serious adverse events
| Measure |
Capecitabine
n=228 participants at risk
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.88%
2/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Abdominal abscess
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Colon cancer
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Ileus
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Stomatitis
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
General disorders
Death
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
General disorders
Disease progression
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Nervous system disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Surgical and medical procedures
Hospitalisation
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Vascular disorders
Hypertensive crisis
|
0.44%
1/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
Other adverse events
| Measure |
Capecitabine
n=228 participants at risk
Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m\^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m\^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hyperbilirubinaemia
|
7.5%
17/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
20/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
12/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
|
Nervous system disorders
Palmar-plantar erythrodysaesthesia syndrome
|
21.1%
48/228 • Up to 25 weeks (from Baseline to the end of safety follow-up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER