Trial Outcomes & Findings for Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery (NCT NCT00290615)

Last Updated: 2013-05-07

Results Overview

Restaging scans occurred every 9 weeks from time of study drug initiation until disease progression. Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. The definitions were: Complete response (CR)- Disappearance of all target lesions Partial response (PD)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.

Results posted on

2013-05-07

Participant Flow

Patients were recruited between October 2005 and June 2007 in the Duke Cancer Center, Duke Oncology Network, and Wake Forest University.

Participant milestones

Participant milestones
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 Participants Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age Continuous	56 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants

PRIMARY outcome

Timeframe: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months.

Population: All subjects who received restaging scans were analyzed.

Outcome measures

Outcome measures
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 Participants Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Response Rate (Percentage of Participants With Partial or Complete Response)	43 percentage of participants with response Interval 25.0 to 63.0

SECONDARY outcome

Timeframe: After all participants went off study drug regimine.

Number of participants with adverse events

Outcome measures

Outcome measures
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 Participants Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Safety and Tolerability	30 participants with adverse event

SECONDARY outcome

Timeframe: From time of treatment until documented progression or death from any cause, whichever came first, assesed up to 60 months.

Disease assessment was performed and recorded according to the Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) Guidelines. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. This is the average number of months participants survived without showing progressive disease.

Outcome measures

Outcome measures
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 Participants Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Progression-free Survival	10.3 months Interval 6.8 to 16.3

SECONDARY outcome

Timeframe: From time of treatment until death from any cause, assesed up to 60 months.

Average months of survival of participants after receiving study drug.

Outcome measures

Outcome measures
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 Participants Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Overall Survival	18.8 months Interval 14.2 to 23.7

OTHER_PRE_SPECIFIED outcome

Timeframe: After study completion

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: After study completion

Outcome measures

Outcome data not reported

Adverse Events

Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab

Serious events: 10 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 participants at risk Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Gastrointestinal disorders Diarrhea	20.0% 6/30 • Number of events 7
Gastrointestinal disorders Dehydration	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 1/30 • Number of events 1
Hepatobiliary disorders Elevated ALT/AST	3.3% 1/30 • Number of events 1
Infections and infestations Sepsis	3.3% 1/30 • Number of events 1
Hepatobiliary disorders Hyperbilirubinemia	3.3% 1/30 • Number of events 1
Renal and urinary disorders Urethral obstruction	3.3% 1/30 • Number of events 1
Vascular disorders Cerebrovascular accident	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Bowel obstruction	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Bowel perforation	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 1/30 • Number of events 1
Vascular disorders Deep Venous Thrombosis	3.3% 1/30 • Number of events 1
General disorders Death	6.7% 2/30 • Number of events 2

Other adverse events

Other adverse events
Measure	Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab n=30 participants at risk Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.
Blood and lymphatic system disorders Neutropenia	33.3% 10/30 • Number of events 10
Blood and lymphatic system disorders Thrombocytopenia	50.0% 15/30 • Number of events 15
Blood and lymphatic system disorders Anemia	10.0% 3/30 • Number of events 3
Vascular disorders Thromboembolism	13.3% 4/30 • Number of events 4
Skin and subcutaneous tissue disorders Skin rash	90.0% 27/30 • Number of events 27
Nervous system disorders Sensory neuropathy	83.3% 25/30 • Number of events 25
Renal and urinary disorders Proteinuria	20.0% 6/30 • Number of events 6
Skin and subcutaneous tissue disorders Paronychia	10.0% 3/30 • Number of events 3
Metabolism and nutrition disorders Hypomagnesium	56.7% 17/30 • Number of events 17
Vascular disorders Hypertension	10.0% 3/30 • Number of events 3
Skin and subcutaneous tissue disorders Hand-foot syndrome	23.3% 7/30 • Number of events 7
General disorders Fatigue	16.7% 5/30 • Number of events 5
Gastrointestinal disorders Vomiting	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Nausea	50.0% 15/30 • Number of events 15
Gastrointestinal disorders Diarrhea	70.0% 21/30 • Number of events 21

Additional Information

Brant Hamel

Duke University Medical Center

Phone: 919-68-1861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place