Trial Outcomes & Findings for High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer (NCT NCT01198548)
NCT ID: NCT01198548
Last Updated: 2014-07-21
Results Overview
The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2014-07-21
Participant Flow
Participant milestones
| Measure |
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Administrative Decision
|
1
|
Baseline Characteristics
High-Dose Cholecalciferol in Treating Patients Receiving Combination Chemotherapy and Bevacizumab as First-Line Therapy For Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
n=10 Participants
Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 8.43 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. The corresponding 95% confidence intervals for the estimated probability will be computed using the method proposed in Clopper and Pearson.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: By week 16Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Trial terminated early. Too few patients to analyze.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
The estimated distribution of OS will be obtained using the product-limit based Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Defined as the time from the start of the study treatment until the date of progression or death from any cause, whichever comes first, assessed up to 3 yearsPopulation: Due to the study's early termination and inadequate number of patients, no patients were analyzed.
The estimated distributions of PFS will be obtained using the product-limit based Kaplan-Meier method. 3 Year Survival Rate
Outcome measures
Outcome data not reported
Adverse Events
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
n=10 participants at risk
Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • Number of events 12
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Intestinal obstruction
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • Number of events 10
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 6
|
|
Infections and infestations
Infection
|
10.0%
1/10 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 6
|
|
Infections and infestations
Wound infection
|
10.0%
1/10 • Number of events 12
|
|
Renal and urinary disorders
Renal failure acute
|
10.0%
1/10 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 5
|
Other adverse events
| Measure |
Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)
n=10 participants at risk
Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin\* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: \*Treatment with oxaliplatin is discontinued after course 8
leucovorin calcium: Given IV
bevacizumab: Given IV
cholecalciferol: Given PO
fluorouracil: Given IV
oxaliplatin: Given IV
pharmacological study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • Number of events 17
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
3/10 • Number of events 42
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
6/10 • Number of events 48
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 5
|
|
Gastrointestinal disorders
Cheilitis
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
5/10 • Number of events 27
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
20.0%
2/10 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 16
|
|
Gastrointestinal disorders
Oesophageal pain
|
10.0%
1/10 • Number of events 5
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
1/10 • Number of events 5
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • Number of events 10
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Number of events 22
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 14
|
|
General disorders
Mucosal inflammation
|
10.0%
1/10 • Number of events 6
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 6
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 5
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 5
|
|
Infections and infestations
Tooth abscess
|
10.0%
1/10 • Number of events 5
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased
|
30.0%
3/10 • Number of events 20
|
|
Investigations
Blood amylase increased
|
10.0%
1/10 • Number of events 5
|
|
Investigations
Haemoglobin
|
10.0%
1/10 • Number of events 5
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Number of events 5
|
|
Investigations
Weight decreased
|
10.0%
1/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
10.0%
1/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
30.0%
3/10 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • Number of events 5
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 6
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 12
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
10.0%
1/10 • Number of events 5
|
|
Reproductive system and breast disorders
Genital pruritus female
|
10.0%
1/10 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • Number of events 6
|
|
Vascular disorders
Hypertension
|
30.0%
3/10 • Number of events 25
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 5
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place