A Phase I/II Study of Induction Conatumumab and Gemcitabine, Followed by Conatumumab, Capecitabine and 3-D Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
OBJECTIVES:
Primary
- To evaluate the maximum tolerated dose of conatumumab up to a target dose of 10 mg/kg
given concurrently with capecitabine and radiotherapy following induction therapy
comprising conatumumab and gemcitabine hydrochloride in patients with locally advanced
pancreatic cancer. (Phase I)
- To evaluate the overall survival of patients treated with this regimen. (Phase II)
Secondary
- To evaluate the safety profile in patients treated with this regimen. (Phase I and II)
- To evaluate the progression-free survival of patients treated with this regimen. (Phase
II)
- To evaluate the primary tumor response rate in patients treated with this regimen.
(Phase II)
- To generate translational research hypotheses. (Phase II)
OUTLINE: This is a multicenter, phase I dose-escalation study of conatumumab, followed by a
phase II study.
- Induction therapy: Patients receive conatumumab IV over 30-60 minutes on days 1 and 15
and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 28 days for 2 courses.
- Conatumumab and chemoradiotherapy: Beginning 14-42 days after the last course of
induction therapy, patients undergo 3-dimensional radiotherapy once daily, 5 days a
week, for 5½ weeks (28 treatments). Patients also receive conatumumab IV over 30-60
minutes on days 1, 15, and 29 and oral capecitabine twice daily, 5 days a week, for 5½
weeks.
- Maintenance therapy: Beginning 28-56 days after completion of chemoradiotherapy,
patients receive conatumumab IV over 30-60 minutes on days 1 and 15 and gemcitabine
hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity (Phase I)
Yes
Christopher H. Crane, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Federal Government
RTOG-0932
NCT01017822
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