Trial Outcomes & Findings for Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer (NCT NCT01128387)

Last Updated: 2019-12-09

Results Overview

Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation \>10 treatment days, 2) \>2 interruptions of radiation per course, 3) a delay in completion of radiation by \>14 days beyond planned treatment schedule, 4) inability to deliver \>80% of planned treatment doses, 5) any infield grade 4 toxicity

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

approximately 18 weeks

Results posted on

2019-12-09

Participant Flow

Participants were recruited from the University of Wisconsin Hospital and Clinics between 2010 and 2013.

Participant milestones

Participant milestones
Measure	Dose Level 1 Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)	Dose Level -1 Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU
Overall Study STARTED	5	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)	Dose Level -1 Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU
Overall Study Physician Decision	0	1

Baseline Characteristics

Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=5 Participants Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU	Dose Level -1 n=6 Participants Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Age, Continuous	60.3 years n=93 Participants	62.6 years n=4 Participants	61.5 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants

PRIMARY outcome

Timeframe: approximately 18 weeks

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU	Dose Level -1 n=6 Participants Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU
MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 20 weeks.

Population: Data was not collected or analyzed for the pathologic response outcome measure.

From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Dose Level -1

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Mark Ritter

University of Wisconsin Carbone Cancer Center

Phone: 608-263-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose Level 1 n=5 participants at risk Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU	Dose Level -1 n=6 participants at risk Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU
General disorders Alanine Amiotransferase (ALT)	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
General disorders Aspartate Aminotransferase (AST)	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
General disorders Bilirubin	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Colitis	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Cardiac disorders Conduction	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Dehydration	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Hemorrhage	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Infections and infestations Infection	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Leukocytes	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Lymphopenia	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Platelets	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Renal and urinary disorders Renal failure	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Cardiac disorders Supraventricular and nodal arrhythmia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Nervous system disorders CNS cerebrovascular ischemia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.

Measure	Dose Level 1 n=5 participants at risk Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,80mg/m2 cisplatin, 1000mg/m2 5FU	Dose Level -1 n=6 participants at risk Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Panitumumab: dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32. 1.5mg/kg Panitumumab,60mg/m2 cisplatin, 750mg/m2 5FU
Ear and labyrinth disorders Tinnitus	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Platelets	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	66.7% 4/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Leukocytes	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	100.0% 6/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Neutrophils (ANC (Absolute Neutrophil Count))	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Hemoglobin	100.0% 5/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	50.0% 3/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Blood and lymphatic system disorders Lymphopenia	80.0% 4/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
General disorders Fatigue	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	66.7% 4/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Skin and subcutaneous tissue disorders Acne	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	83.3% 5/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Skin and subcutaneous tissue disorders Alopecia	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Skin and subcutaneous tissue disorders Rash - Maculopapular	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Dysphagia	80.0% 4/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	83.3% 5/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Mucositis	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	66.7% 4/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Esophagitis	100.0% 5/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Dehydration	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	83.3% 5/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Diarrhea	80.0% 4/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Constipation	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Nausea	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Thrush	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Dysgeusia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Belching	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Mouth sores	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Weight loss	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Anorexia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Gastrointestinal disorders Esophageal pain	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Creatinine	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Hypoamagnesemia	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Low sodium (hyponatremia)	60.0% 3/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Low calcium (hypocalcemia)	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	33.3% 2/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Nervous system disorders Neuropothy	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Nervous system disorders Depression	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Nervous system disorders Syncope	0.00% 0/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	16.7% 1/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
General disorders Pain	40.0% 2/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.
Renal and urinary disorders Nocturia	20.0% 1/5 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.	0.00% 0/6 • Adverse event data were collected for up to 6 years, 3 months. Adverse events were collected at weekly visits.