Trial Outcomes & Findings for Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer (NCT NCT00462501)
NCT ID: NCT00462501
Last Updated: 2016-01-20
Results Overview
This will be assessed on the basis of the surgical pathology report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
3 years
Results posted on
2016-01-20
Participant Flow
Participant milestones
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Overall Study
Not treated
|
3
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Combination Chemotherapy and Bevacizumab With or Without Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer
Baseline characteristics by cohort
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
n=35 Participants
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsThis will be assessed on the basis of the surgical pathology report.
Outcome measures
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
n=30 Participants
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Complete Pathologic Response
Partial Response
|
21 participants
|
|
Complete Pathologic Response
Complete Response
|
8 participants
|
|
Complete Pathologic Response
Unknown
|
1 participants
|
Adverse Events
Chemotherapy and Bevacizumab With or Without Radiation
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
n=35 participants at risk
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmia, other
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary arrest
|
2.9%
1/35 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.7%
2/35 • Number of events 2
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Wound infection
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.9%
1/35 • Number of events 1
|
|
Infections and infestations
Infection, other
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rectal anastomotic leak
|
5.7%
2/35 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/35 • Number of events 1
|
|
Cardiac disorders
Chest pain - cardiac
|
2.9%
1/35 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder pain
|
2.9%
1/35 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.9%
1/35 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/35 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
1/35 • Number of events 1
|
Other adverse events
| Measure |
Chemotherapy and Bevacizumab With or Without Radiation
n=35 participants at risk
FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist's reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
8.6%
3/35 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increase
|
5.7%
2/35 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
5/35 • Number of events 9
|
|
Investigations
Alkaline phosphatase increase
|
8.6%
3/35 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
8.6%
3/35 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35 • Number of events 3
|
|
Investigations
Creatinine increase
|
8.6%
3/35 • Number of events 4
|
|
General disorders
Fatigue
|
11.4%
4/35 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.1%
13/35 • Number of events 53
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.7%
2/35 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
48.6%
17/35 • Number of events 94
|
|
Investigations
White blood cell decreased
|
40.0%
14/35 • Number of events 23
|
|
Investigations
Lipase increased
|
5.7%
2/35 • Number of events 7
|
|
Investigations
Lymphocyte count decreased
|
28.6%
10/35 • Number of events 17
|
|
Gastrointestinal disorders
Mucositis-Oral
|
11.4%
4/35 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
14.3%
5/35 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
7/35 • Number of events 8
|
|
Investigations
Neutrophil count decreased
|
54.3%
19/35 • Number of events 42
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.6%
10/35 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.4%
4/35 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Number of events 2
|
Additional Information
Dr. Leonard Saltz
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place