Trial Outcomes & Findings for Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer (NCT NCT00159432)

Last Updated: 2014-07-29

Results Overview

Progression-free survival was measured from the start of treatment until the time the subject is first recorded as having disease progression (progression = 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed or baseline, progression of non-measurable disease in the opinion of treating physician, appearance of new lesion/site, death due to disease), or death due to any cause. If a subject has not progressed or died, progression-free survival was censored at the time of last follow-up or the start of another treatment, whichever came first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2014-07-29

Participant Flow

Recruitment for this trial opened in February 2005 and closed in May 2009. All subjects were seen at USC.

This trial has no pre-assignment. All subjects were given the same treatment.

Participant milestones

Participant milestones
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Overall Study STARTED	63
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Lack of Efficacy	8

Baseline Characteristics

Study of Oxaliplatin, Capecitabine and Bevacizumab as First Line Treatment for Patients With Advanced Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine n=63 Participants oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=93 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants
Sex: Female, Male Female	40 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	21 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	4 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=93 Participants
Region of Enrollment United States	63 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.

Outcome measures

Outcome measures
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine n=63 Participants oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Median Time for Progression Free Survival	15.8 Months Interval 11.5 to 64.3

SECONDARY outcome

Timeframe: Baseline, every 2 weeks of each cycle, and at end of treatment, up to 18 months.

Population: All enrolled participants who receive the first course of treatment are included in the analysis as per protocol.

Summary of grade 3 (per CTCAE v3.0) or higher toxicities which generally is described as a severe adverse reaction or symptom.

Outcome measures

Outcome measures
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine n=63 Participants oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Number of Participants With Grade 3 or Higher Toxicity	51 Participants

Adverse Events

Oxaliplatin Followed by Bevacizumab, With Capecitabine

Serious events: 51 serious events

Other events: 63 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine n=63 participants at risk oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Investigations Alkaline phosphatase	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	6.3% 4/63 • Number of events 4 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Anorexia	7.9% 5/63 • Number of events 7 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Colitis, infectious	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Constipation	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
General disorders Death not associated with CTCAE term (Death NOS)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Dehydration	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Diarrhea	27.0% 17/63 • Number of events 22 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Distension/bloating, abdominal	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
General disorders Fatigue (asthenia, lethargy, malaise)	6.3% 4/63 • Number of events 6 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Blood and lymphatic system disorders Febrile neutropenia (fever, unknown origin w/o clinically or microbiologically documented infection)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Injury, poisoning and procedural complications Fracture	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	3.2% 2/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Blood and lymphatic system disorders Hemoglobin	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Hemorrhage, GI (colon)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Vascular disorders Hypertension	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Infections and infestations Infection with unknown ANC (Wound)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Lipase	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Nausea	12.7% 8/63 • Number of events 8 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Nervous system disorders Neuropathy: sensory	20.6% 13/63 • Number of events 16 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Neutrophils/granulocytes (ANC/AGC)	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Renal and urinary disorders Obstruction, GU (Ureter)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Pain (Abdomen NOS)	12.7% 8/63 • Number of events 10 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Musculoskeletal and connective tissue disorders Pain (Bone)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Pain (Rectum)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Renal and urinary disorders Proteinuria	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	20.6% 13/63 • Number of events 15 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Injury, poisoning and procedural complications Thrombosis/thrombus/embolism	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Vomiting	11.1% 7/63 • Number of events 8 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.

Other adverse events

Other adverse events
Measure	Oxaliplatin Followed by Bevacizumab, With Capecitabine n=63 participants at risk oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Alkaline phosphatase	30.2% 19/63 • Number of events 30 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	6.3% 4/63 • Number of events 4 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	31.7% 20/63 • Number of events 31 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Amylase	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Anorexia	54.0% 34/63 • Number of events 47 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations AST, SGOT (serum glutamic oxaloacetic transaminase)	42.9% 27/63 • Number of events 53 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Bilirubin (hyperbilirubinemia)	34.9% 22/63 • Number of events 35 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Constipation	52.4% 33/63 • Number of events 57 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Creatinine	3.2% 2/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Dehydration	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Diarrhea	58.7% 37/63 • Number of events 82 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Nervous system disorders Dizziness	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
General disorders Edema: limb	7.9% 5/63 • Number of events 5 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
General disorders Fatigue (asthenia, lethargy, malaise)	82.5% 52/63 • Number of events 98 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
General disorders Fever (in absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	39.7% 25/63 • Number of events 47 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Hail loss/alopecia (scalp or body)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Blood and lymphatic system disorders Hemoglobin	87.3% 55/63 • Number of events 107 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Hemorrhage, GI (Anus)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Hemorrhage, GI (Oral cavity)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Hemorrhage, GI (Rectum)	6.3% 4/63 • Number of events 4 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Hemorrhage, GI (Upper GI NOS)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Renal and urinary disorders Hemorrhage, GU (Urinary NOS)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory (Nose)	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Vascular disorders Hypertension	30.2% 19/63 • Number of events 26 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations INR (International Normalized Ratio of prothrombin time)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Psychiatric disorders Insomnia	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Leukocytes (total WBC)	1.6% 1/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Psychiatric disorders Mood alteration (Depression)	4.8% 3/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Mucositis/stomatitis (Oral cavity)	33.3% 21/63 • Number of events 28 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Nail changes	41.3% 26/63 • Number of events 32 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Nausea	65.1% 41/63 • Number of events 73 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Nervous system disorders Neuropathy: sensory	93.7% 59/63 • Number of events 147 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Neutrophils/granulocytes (ANC/AGC)	28.6% 18/63 • Number of events 31 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Pain (Abdomen NOS)	66.7% 42/63 • Number of events 74 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Musculoskeletal and connective tissue disorders Pain (Back)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Musculoskeletal and connective tissue disorders Pain (Chest/thorax NOS)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Nervous system disorders Pain (Head/headache)	14.3% 9/63 • Number of events 16 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Musculoskeletal and connective tissue disorders Pain (Muscle)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Pain (Rectum)	3.2% 2/63 • Number of events 3 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Investigations Platelets	33.3% 21/63 • Number of events 32 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Renal and urinary disorders Proteinuria	36.5% 23/63 • Number of events 31 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Rash/desquamation	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	79.4% 50/63 • Number of events 110 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Skin and subcutaneous tissue disorders Sweating (diaphoresis)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Nervous system disorders Taste alteration (dysgeusia)	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	1.6% 1/63 • Number of events 1 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Vascular disorders Thrombosis/thrombus/embolism	3.2% 2/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Gastrointestinal disorders Vomiting	28.6% 18/63 • Number of events 31 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.
Injury, poisoning and procedural complications Wound complication, non-infectious	1.6% 1/63 • Number of events 2 • Baseline, every 2 weeks of each cycle, and treatment end, up to 18 months.

Additional Information

Victoria Soto, Project Specialist

USC Norris Comprehensive Cancer Center

Phone: 323-226-6384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place