Trial Outcomes & Findings for Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer (NCT NCT00002842)

Last Updated: 2017-04-11

Results Overview

Estimated using the product-limit method of Kaplan and Meier. Disease free survival, defined as first documented evidence of treatment failure. Acceptable evidence includes: Anastomotic - positive cytology or biopsy; Abdominal, pelvic and retroperitoneal nodes - progressively enlarging node as evidenced by 2 CT scans separated by at least a 4 week interval, ureteral obstruction in the presence of a mass as documented on CT scan; Peritoneum - positive cytology or biopsy, progressively enlarged intraperitoneal solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Ascites - positive cytology or biopsy; Liver - positive cytology or biopsy; Pelvic mass - positive cytology or biopsy, progressively enlarging intrapelvic solid mass as evidenced by 2 CT scans separated by at least 4 weeks; Abdominal wall - positive cytology or biopsy; Lung - positive cytology or biopsy or presence of multiple pulmonary nodules; Bone marrow - positive cytology, aspiration or biopsy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

2 years after treatment

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
Overall Study STARTED	49
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
Overall Study ineligible for surgical resection	27

Baseline Characteristics

Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin n=22 Participants Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years after treatment

Outcome measures

Outcome measures
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin n=22 Participants Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
2 Year Disease-free Survival .	9 percentage of participants Interval 2.0 to 34.0

Adverse Events

Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin

Serious events: 8 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin n=22 participants at risk Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
Gastrointestinal disorders Diarrhea	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AGC	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Hepatic Resection/Portal Vein FUdr/Systemic 5-FU & Leucovorin n=22 participants at risk Patients receive floxuridine via portal vein infusion from days 1-14. Systemic chemotherapy consists of leucovorin calcium on days 8-14 and fluorouracil on days 9-13. Courses repeat every 4 weeks for a total of 12 weeks floxuridine: Starting dose of 0.2 mg/kg/day for 14 consecutive days. fluorouracil: 300 mg/m2/day by intravenous bolus 24 hours apart for 5 consecutive days. leucovorin calcium: 500 mg/m2/day by continuous intravenous infusion beginning 24 hours prior to the first dose of 5-FU and continuing until 12 hours following the last dose of 5-FU. adjuvant therapy: Chemotherapy given after hepatic resection conventional surgery: Hepatic resection
Cardiac disorders Dysrhythmias	9.1% 2/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Other Misc	40.9% 9/22 • Number of events 14 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericardial	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Stomatitis	31.8% 7/22 • Number of events 10 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Weight (Food Intake)	4.5% 1/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	50.0% 11/22 • Number of events 26 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia supraventricular	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	22.7% 5/22 • Number of events 8 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Ascites	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Colitis	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	18.2% 4/22 • Number of events 4 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	90.9% 20/22 • Number of events 66 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	31.8% 7/22 • Number of events 10 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	68.2% 15/22 • Number of events 31 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders	13.6% 3/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Proctitis	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal pain	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	54.5% 12/22 • Number of events 19 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	54.5% 12/22 • Number of events 20 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	13.6% 3/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever (no infection)	31.8% 7/22 • Number of events 15 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	9.1% 2/22 • Number of events 7 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	9.1% 2/22 • Number of events 5 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations AGC	22.7% 5/22 • Number of events 14 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	50.0% 11/22 • Number of events 41 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline Phosphatase	22.7% 5/22 • Number of events 18 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	36.4% 8/22 • Number of events 26 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	54.5% 12/22 • Number of events 32 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine	4.5% 1/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	4.5% 1/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations HGB/HCT	36.4% 8/22 • Number of events 32 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	9.1% 2/22 • Number of events 9 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	22.7% 5/22 • Number of events 8 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	45.5% 10/22 • Number of events 21 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	4.5% 1/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	18.2% 4/22 • Number of events 7 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	27.3% 6/22 • Number of events 12 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelets	18.2% 4/22 • Number of events 17 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Prothrombin Time	18.2% 4/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations SGOT/SGT	40.9% 9/22 • Number of events 39 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations WBC	31.8% 7/22 • Number of events 19 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	13.6% 3/22 • Number of events 5 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	31.8% 7/22 • Number of events 8 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	27.3% 6/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	45.5% 10/22 • Number of events 31 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	36.4% 8/22 • Number of events 25 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	50.0% 11/22 • Number of events 29 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	13.6% 3/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	13.6% 3/22 • Number of events 4 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	13.6% 3/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cortical/State of Consciousness	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	13.6% 3/22 • Number of events 3 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	9.1% 2/22 • Number of events 4 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Motor Activity	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral Nervous System Sensory	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	22.7% 5/22 • Number of events 7 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	18.2% 4/22 • Number of events 7 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Mood	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	9.1% 2/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	13.6% 3/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Extensive Skin Rash	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Local Skin Rash	13.6% 3/22 • Number of events 4 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	40.9% 9/22 • Number of events 12 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Sweating	4.5% 1/22 • Number of events 2 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	4.5% 1/22 • Number of events 1 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	18.2% 4/22 • Number of events 6 • Adverse events occurring over a period of 7 years and 6 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Jeffrey Longmate, Ph.D.

City of Hope

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place