Trial Outcomes & Findings for A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer (NCT NCT00642603)

Last Updated: 2018-03-29

Results Overview

PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

From first patient enrolled up to approximately 48 months

Results posted on

2018-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	XELOX + Bevacizumab (Q2W) Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.	XELIRI + Bevacizumab (Q2W) Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
Overall Study STARTED	21	20
Overall Study Safety Population	19	20
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	21	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XELOX + Bevacizumab (Q2W) n=21 Participants Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.	XELIRI + Bevacizumab (Q2W) n=20 Participants Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.	Total n=41 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 12.06 • n=5 Participants	60.6 years STANDARD_DEVIATION 9.89 • n=7 Participants	62.3 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first patient enrolled up to approximately 48 months

Population: This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.

PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

Outcome measures

Outcome data not reported

Adverse Events

XELOX + Bevacizumab (Q2W)

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

XELIRI + Bevacizumab (Q2W)

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	XELOX + Bevacizumab (Q2W) n=19 participants at risk Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.	XELIRI + Bevacizumab (Q2W) n=20 participants at risk Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	5.3% 1/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	10.0% 2/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Diarrhoea	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Clostridium Difficile Colitis	5.3% 1/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Infections and infestations Pneumonia	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Cardiac disorders Hypertrophic Cardiomyopathy	5.3% 1/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
General disorders Asthenia	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	5.3% 1/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	0.00% 0/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Nervous system disorders Lacunar Infarction	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
Vascular disorders Deep Vein Thrombosis	0.00% 0/19 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.	5.0% 1/20 Safety analysis population = received at least one dose of study medication. Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.

Other adverse events

Additional Information

Medical Communications

Genentech, Inc.

Phone: 800-821-8590

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