Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Patrick Joseph Loehrer Sr.
Study ID
NCT03213626
Phase
PHASE2
Status
Terminated

Conditions

  • Pancreatic Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 13, 2017
Status verified
Aug 2020
Primary completion
Apr 15, 2019
Completion
Nov 18, 2019

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib + erlotinib

Primary Outcome Measure

Objective (Radiographic) Response [ Time Frame: 8 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana University Health HospitalIndianapolisIndiana46202-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-

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By research site
Indiana University Health Hospital· Indianapolis, INIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, IN

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