Trial Outcomes & Findings for Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon (NCT NCT00314353)

Results Overview

Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Results posted on

2021-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine, Oxaliplatin, Bevacizumab	Capecitabine, Irinotecan, Bevacizumab
Protocol Therapy (8 Cycles) STARTED	4	3
Protocol Therapy (8 Cycles) COMPLETED	2	0
Protocol Therapy (8 Cycles) NOT COMPLETED	2	3
Follow-up STARTED	3	0
Follow-up COMPLETED	3	0
Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine, Oxaliplatin, Bevacizumab n=4 Participants	Capecitabine, Irinotecan, Bevacizumab n=3 Participants	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Age, Continuous	65.8 years STANDARD_DEVIATION 9.0 • n=99 Participants	63.0 years STANDARD_DEVIATION 13.2 • n=107 Participants	64.6 years STANDARD_DEVIATION 10.1 • n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Region of Enrollment United States	4 participants n=99 Participants	3 participants n=107 Participants	7 participants n=206 Participants

PRIMARY outcome

Timeframe: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Population: Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Population: Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab

Population: Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Population: Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.

Population: Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.

Outcome measures

Outcome data not reported

Adverse Events

Capecitabine, Oxaliplatin, Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Capecitabine, Irinotecan, Bevacizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Diana Gosik

NSABP Foundation, Inc.

Phone: 412-330-4692

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60