Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD; NSC# 712227) or in Combination With Weekly Pactilaxel (NSC #673089) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This phase I trial is studying the side effects and best dose of TLR8 agonist VTX-2337 and pegylated liposomal doxorubicin hydrochloride in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or peritoneal cavity cancer. Biological therapies, such as TLR8 agonist VTX-2337, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving TLR8 agonist VTX-2337 together with pegylated liposomal doxorubicin hydrochloride or paclitaxel may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated doses (MTD) and dose limiting toxicities (DLTs) of
VTX-2337 when administered in combination with pegylated liposomal doxorubicin (PLD; Doxil,
Lipodox™) 40 mg/m2 in Regimen 1 and when administered in combination with weekly paclitaxel
80 mg/m2 in Regimen 2, and the associated DLTs based on adverse events that occur in cycle 1
for each of these combinations in women with recurrent or persistent, epithelial ovarian,
fallopian tube or primary peritoneal cancer.
II. To examine the tolerability of the combination at the MTD of VTX-2337 assessed in
combination with PLD 40 mg/m2 and with PLD 50 mg/m2 in Regimen 1 and in combination with
weekly paclitaxel in Regimen 2.
III. To determine recommended phase II doses (RP2D) of VTX-2337 in combination with PLD in
Regimen 1 and in combination with weekly paclitaxel in Regimen 2.
SECONDARY OBJECTIVES:
I. To assess the biological effects (immune activation) of VTX-2337 in combination with PLD
in Regimen 1 and in combination with weekly paclitaxel in Regimen 2.
II. To assess the pharmacokinetics in patients receiving VTX-2337 in combination with PLD in
Regimen 1 and in combination with weekly paclitaxel in Regimen 2.
III. To assess the tolerability (including CTCAE v4 Grade 3/4 allergic reaction) of weekly
paclitaxel 80 mg/m2 when administered without corticosteroid premedication (Regimen 2 only).
TERTIARY OBJECTIVES:
I. To assess the anti-tumor activity of VTX-2337 when administered concomitantly with PLD in
Regimen 1 and when administered concomitantly with weekly paclitaxel in Regimen 2 in
patients with recurrent or persistent epithelial ovarian fallopian tube or primary
peritoneal cancer.
II. To assess the effect of TLR8 polymorphisms on the biological (immune) and clinical
effects of VTX-2337 in combination with PLD in Regimen 1 and in combination with weekly
paclitaxel in Regimen 2.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive TLR8 agonist VTX-2337 subcutaneously (SC) on days 3, 10, and 17 and
pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 or TLR8 agonist
VTX-2337 subcutaneously on days 1, 8, and 15 and paclitaxel IV over 60 minutes on days 1, 8,
and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
Blood samples are collected periodically during courses 1 and 2 for pharmacokinetic,
pharmacogenomic, and other research studies. After completion of study treatment, patients
are followed up every 3 months for 1 year.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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