Esophageal cancer, gastric cancer, small intestine cancer, urothelial cancer, breast cancer
Conditions
Interventions
Necitumumab 800 mg, IV over 60 minutes, given o n days 1 and 8, repeated every 3 weeks
Sponsors
Nakanishi Kouki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Written consent has been obtained from the pat ient after sufficient explanation of the study contents prior to enrollment in the study. 2)Written consent has been obtained from the patient for the collection of blood for ctDNA analysis after sufficient explanation has been given. 3)The patient's age is 20 years or older at the time of obtaining consent. 4)Histologically or cytologically diagnosed with es ophageal, gastric, small intestinal, urothelial, or breast cancer. 5)Diagnosed as EGFR gene amplification positive by FoundationOne CDx or NCC Oncopanel Syste musing tumor specimens, or by FoundationOne Liquid CDx or Guardant360 using blood specimens. 6)No genetic abnormalities in EGFR(excluding am plification),RAS,BRAF,MAP2K,or ERBB2. 7)Unresectable advanced or recurrent esophagea l, gastric, small intestinal, urothelial, or breast cancer. 8)No metastasis to the symptomatic central nervo us system (brain,spinal cord,or meninges). 9)Has measurable lesion according to RECIST guidelines version 1.1 10)Refractory or intolerant to standard chemotherapy. Esophageal, small bowel, and urothelial cancer: refractory/intolerant to at least 1 regimen. Gastric cancer: refractory/intolerant to at least 2 regimens Hormone receptor negative breast cancer: Prior anthracycline and taxane therapy Hormone receptor positive breast cancer: refractory to hormone therapy and prior anthracycline and taxane therapy 11)ECOG Performance Status of 0 or 1 12)Expected to survive for at least 3 months 13)Latest laboratory values within 7 days prior to enrollment (1)Neutrophil count >=1,500/mm3 (2)Hemoglobin >= 8.0 g/dL (3)Platelet count >= 100,000/mm3 (4)Total bilirubin 1.5 mg/dL is also eligible if creatinine clearance (CCr) >= 40 mL/min is met.
Exclusion criteria
Exclusion criteria: 1)Has active multiple cancers 2)Has a local infection or systemic active infection that requires treatment 3)Clinically problematic psychiatric disorders that would make enrollment in the study difficult 4) The patient has the following complications (1)Renal failure (2)Liver failure (3)Interstitial pneumonia/pulmonary fibrosis (4)Unstable angina pectoris (5)Other complications that the physician in charg e judges to be serious 5)Known to be HER2 positive Gastric cancer, breast cancer: HER2 test required (only HER2 negative patients are eligible) Esophageal cancer, small intestine cancer, urothelial cancer: Not ineligible even if HER2 test is not performed. 6)History of treatment with EGFR inhibitors 7)History of severe hypersensitivity 8)Received any of the following treatments within the specified time period prior to enrollment in this study (1)Prior therapy (chemotherapy, molecular target ed therapy, antibody therapy, hormone therapy, immunotherapy, radiation therapy) within 2 weeks prior to enrollment (2)Underwent major surgery (minor surgery such as lymph node biopsy, needle biopsy, or portimpl antation is not applicable) within 2 weeks prior to enrollment. 9) Pregnant women, lactating women, women who may be currently pregnant, or men and women who do not intend to use contraception. 10) Other cases deemed inappropriate by the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate: ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response: DoR Progression-free survival: PFS Overall survival: OS Time to treatment failure: TTF Disease control rate: DCR Incidence of adverse events The rate of tumor shrinkage Dose intensity Association between EGFR copy number (CN) before treatment and efficacy Association between change in EGFR CN (before treatment and before the initiation of the second course) and efficacy | — |
Contacts
Public ContactToshiki Masuishi
Aichi Cancer Center Hospital
Outcome results
None listed