A Phase I Study of Induction AMG 479 and Gemcitabine, Followed by AMG 479, Capecitabine, and 3D-Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
- To evaluate the maximum dose of ganitumab, up to a target dose of 20 mg/kg, given
concurrently with capecitabine and radiotherapy following induction ganitumab and
gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.
- To evaluate the safety profile of induction therapy comprising ganitumab and
gemcitabine hydrochloride, followed by ganitumab and concurrent chemoradiation, and
subsequently by maintenance ganitumab and gemcitabine hydrochloride until disease
progression in patients with locally advanced pancreatic cancer.
- To evaluate response and overall survival of patients treated at the maximum dose of
ganitumab given concurrently with capecitabine and radiotherapy following induction
ganitumab and subsequently followed by maintenance ganitumab and gemcitabine
hydrochloride until disease progression.
OUTLINE: This is a multicenter, dose-escalation study of ganitumab followed by an expanded
Induction therapy: Patients receive ganitumab IV over 1-2 hours on days 1 and 15 and
gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and 22. Treatment repeats every
28 days for 2 courses.
Concurrent therapy: Beginning 10-28 days later, patients undergo 3-dimensional conformal
radiotherapy once daily, 5 days a week for 5.5 weeks beginning on day 1. Patients also
receive concurrent ganitumab IV over 1-2 hours on days 1, 15, and 29 and capecitabine orally
(PO) twice daily on days 1-5 weekly for 5.5 weeks.
Maintenance therapy: Beginning 21-42 days later, patients receive ganitumab IV over 1-2
hours on days 1 and 15 and gemcitabine hydrochloride IV over 30 minutes on days 1, 15, and
22. Courses repeat every 28 days in the absence of disease progression or unacceptable
After completion of study therapy, patients are followed up every 3 months for 2 years,
every 4 months for 1 year, and then annually thereafter.
Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity of ganitumab and capecitabine given concurrently with radiotherapy
Christopher H. Crane, MD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|Rhode Island Hospital Comprehensive Cancer Center||Providence, Rhode Island 02903|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Northmain Radiation Oncology||Providence, Rhode Island 02904|