Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma
Status:
Terminated
Trial end date:
2019-11-18
Target enrollment:
Participant gender:
Summary
This is an open-label, single arm, phase II trial. Safety will be monitored on an ongoing
basis. Laboratory testing (chemistry, hematology tests) will be performed every 2 weeks for
the first 8 weeks followed by assessments every 4 weeks. Other safety evaluations including
EKGs, urinalysis, coagulation and thyroid function studies will be performed at regular
intervals.
Adverse event seriousness, severity grade, and relationship to study treatment will be
assessed by the investigator. Severity grade will be defined by the National Cancer Institute
(NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Tumors will be assessed by contrast enhanced CT or MRI every 8 weeks. Pre-treatment tissue
will be obtained via CT-guided FNA biopsy or collected during resection. However, archival
tissue will also be requested, when available and if adequate for testing. Post-treatment
tissue will be obtained on Day 15 (i.e., Week 3/Day 1) via CT-guided FNA biopsy. All tumor
tissue from eligible patients will be utilized for the correlative studies which are outlined
in this trial.
Each subject's course will consist of three periods:
- A Pre-Treatment Period in which subjects are consented and undergo screening assessments
to be qualified for the study;
- A Treatment Period in which subjects receive study treatment and undergo study
assessments. Patients who meet the eligibility criteria will be treated with
cabozantinib orally at 40 mg daily and erlotinib orally at 100 mg daily without breaks;
- A Post-Treatment Period in which subjects no longer receive study treatment but undergo
follow-up study assessments and contacts.