Trial Outcomes & Findings for Safety and Efficacy Study Using Bevacizumab, Capecitabine and Oxaliplatin for Colorectal Cancer (NCT NCT00177307)
NCT ID: NCT00177307
Last Updated: 2016-07-12
Results Overview
time from start of protocol therapy until objective tumor progression or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 27 Months
Results posted on
2016-07-12
Participant Flow
A total of 40 patients were enrolled, but one subject withdrew before starting therapy.
Participant milestones
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety and Efficacy Study Using Bevacizumab, Capecitabine and Oxaliplatin for Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 Participants
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 27 Monthstime from start of protocol therapy until objective tumor progression or death
Outcome measures
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 Participants
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Progression Free Survival (PFS)
|
8.6 Months
Interval 4.7 to 10.2
|
SECONDARY outcome
Timeframe: Up to 27 monthsPercentage of partial responses (PR) + complete responses (CR).
Outcome measures
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 Participants
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Response Rate (RR)
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 40 monthstime from start of protocol therapy until death from any cause
Outcome measures
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 Participants
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Overall Survival
|
17.2 Months
Interval 10.4 to 24.2
|
SECONDARY outcome
Timeframe: Up to 40 monthsProbability of being alive at 1-, 2-, and 3-years from start of protocol therapy
Outcome measures
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 Participants
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
1-, 2-, and 3-year Overall Survival
1 year-overall survival
|
62 percent chance
|
|
1-, 2-, and 3-year Overall Survival
2 year-overall survival
|
36 percent chance
|
|
1-, 2-, and 3-year Overall Survival
3 year-overall survival
|
24 percent chance
|
Adverse Events
Oxaliplatin, Capecitabine, and Bevacizumab
Serious events: 25 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 participants at risk
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39
|
|
Investigations
Thrombocytopenia
|
5.1%
2/39
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
7/39
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
10.3%
4/39
|
|
Nervous system disorders
Neuropathy
|
10.3%
4/39
|
|
Gastrointestinal disorders
Bowel perforation
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Bleeding
|
2.6%
1/39
|
Other adverse events
| Measure |
Oxaliplatin, Capecitabine, and Bevacizumab
n=39 participants at risk
Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity
Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).
Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
2.6%
1/39
|
|
Investigations
Alkaline phosphatase
|
2.6%
1/39
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
2.6%
1/39
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.1%
2/39
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
5.1%
2/39
|
|
Investigations
Amylase
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Anorexia
|
46.2%
18/39
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
2.6%
1/39
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.1%
2/39
|
|
Nervous system disorders
Ataxia (incoordination)
|
2.6%
1/39
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
2.6%
1/39
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
5.1%
2/39
|
|
Gastrointestinal disorders
Constipation
|
28.2%
11/39
|
|
General disorders
Constitutional Symptoms - Other
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39
|
|
Renal and urinary disorders
Cystitis
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Dehydration
|
15.4%
6/39
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
5.1%
2/39
|
|
Gastrointestinal disorders
Diarrhea
|
41.0%
16/39
|
|
Nervous system disorders
Dizziness
|
20.5%
8/39
|
|
Eye disorders
Dry eye syndrome
|
2.6%
1/39
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
3/39
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
7.7%
3/39
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.3%
4/39
|
|
General disorders
Edema: limb
|
7.7%
3/39
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
69.2%
27/39
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 cells/L)
|
20.5%
8/39
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
2/39
|
|
Vascular disorders
Flushing
|
2.6%
1/39
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
2.6%
1/39
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
20.5%
8/39
|
|
Blood and lymphatic system disorders
Hemoglobin
|
35.9%
14/39
|
|
Gastrointestinal disorders
Hemorrhage, GI, Lower GI NOS
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, Mediastinum
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory, Respiratory tract NOS
|
2.6%
1/39
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.6%
1/39
|
|
Vascular disorders
Hypertension
|
5.1%
2/39
|
|
Vascular disorders
Hypotension
|
2.6%
1/39
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Joint
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
2.6%
1/39
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Wound
|
2.6%
1/39
|
|
General disorders
Injection site reaction/extravasation changes
|
17.9%
7/39
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
2.6%
1/39
|
|
Investigations
Leukocytes (total WBC)
|
30.8%
12/39
|
|
Investigations
Lipase
|
2.6%
1/39
|
|
Psychiatric disorders
Mood alteration, Anxiety
|
7.7%
3/39
|
|
Psychiatric disorders
Mood alteration, Depression
|
7.7%
3/39
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.6%
1/39
|
|
Gastrointestinal disorders
Nausea
|
56.4%
22/39
|
|
Nervous system disorders
Neurology - Other
|
35.9%
14/39
|
|
Nervous system disorders
Neuropathy: motor
|
5.1%
2/39
|
|
Nervous system disorders
Neuropathy: sensory
|
59.0%
23/39
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
28.2%
11/39
|
|
Gastrointestinal disorders
Obstruction, GI, Small bowel NOS
|
2.6%
1/39
|
|
Eye disorders
Ocular/Visual - Other
|
7.7%
3/39
|
|
General disorders
Pain - Other
|
5.1%
2/39
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
30.8%
12/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
7.7%
3/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Bone
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Buttock
|
2.6%
1/39
|
|
General disorders
Pain, Chest/thorax NOS
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
12.8%
5/39
|
|
General disorders
Pain, Face
|
2.6%
1/39
|
|
Nervous system disorders
Pain, Head/headache
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Joint
|
2.6%
1/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Muscle
|
5.1%
2/39
|
|
Musculoskeletal and connective tissue disorders
Pain, Neck
|
2.6%
1/39
|
|
Gastrointestinal disorders
Perforation, GI, Small bowel NOS
|
0.00%
0/39
|
|
Investigations
Platelets
|
17.9%
7/39
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.8%
5/39
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
41.0%
16/39
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
7.7%
3/39
|
|
General disorders
Rigors/chills
|
12.8%
5/39
|
|
Nervous system disorders
Seizure
|
2.6%
1/39
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.1%
2/39
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
2.6%
1/39
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
2.6%
1/39
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
2.6%
1/39
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
5.1%
2/39
|
|
Nervous system disorders
Syncope (fainting)
|
2.6%
1/39
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
15.4%
6/39
|
|
Nervous system disorders
Tremor
|
5.1%
2/39
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
2.6%
1/39
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
2.6%
1/39
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
2.6%
1/39
|
|
Gastrointestinal disorders
Vomiting
|
41.0%
16/39
|
|
Investigations
Weight gain
|
2.6%
1/39
|
|
Investigations
Weight loss
|
17.9%
7/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place