CLINICAL TRIAL SUMMARY

MDACC Study No:GOG3003 (clinicaltrials.gov NCT No: NCT01666444)
Title:A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 (IND #78,416) in Combination with Pegylated Liposomal Doxorubicin (PLD) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Principal Investigator:Nicole Fleming
Treatment Agent:Doxorubicin; VTX-2337
Study Status:Closed
Study Description:The purpose of this study is to compare pegylated liposomal doxorubicin (PLD; a
standard chemotherapy) to PLD in combination with VTX-2337 (a new type of drug
that stimulates the immune system) to see if it helps your cancer tumors stop
growing or shrink, and if it helps women with your type of cancer live longer.

Standard treatment for your type of cancer may consist of a variety of
chemotherapy drugs which includes paclitaxel, topotecan and PLD. VTX-2337 is an
experimental drug (not approved by the Food and Drug Administration, FDA) that
stimulates your immune system and may help your body kill cancer cells. It is
given subcutaneously (under the skin).

PLD is a special formulation of the drug doxorubicin, in which the doxorubicin
is wrapped in a fat bubble (liposome). This is done to increase the amount of
drug that reaches the tumor and to decrease the side effects. PLD is a standard
chemotherapy, and is used for patients with your type of cancer if other
chemotherapy drugs (carboplatin, paclitaxel) stop working. It is given
intravenously (IV; into a vein in your arm). The combination of PLD with
VTX-2337 is experimental.

PLD is an FDA-approved treatment for women with ovarian cancer. In prior
studies, approximately 15–20% of women who received PLD for relapsed ovarian
cancer experienced a temporary shrinkage or disappearance of their tumor. In
these studies, treatment with PLD delayed the time until the cancer worsened
(e.g. the time until the tumor grew) by an average of about 4 months. Doctors
hope that treatment with the combination of PLD plus VTX-2337 will be more
effective against cancer compared to treatment with PLD alone.

The combination of PLD plus VTX-2337 has been evaluated in a previous study of
13 patients. Results show that the two drugs can be given together without too
many serious side effects. In addition, research blood tests show that VTX-2337
stimulated the immune system in all the patients. The study also provided
evidence that PLD + VTX-2337 may temporarily stop some patients’ tumors from
growing (this happened in 7 patients), or it may help cancer tumors temporarily
shrink and/or disappear (this happened in 1 patient).

In addition to the treatment part of this study, the researchers plan to test
samples of your tumor and some of your blood. You cannot participate in this
study if you do not agree to provide these specimens for this research. The
purpose of this research is to examine the impact the study drugs have on tumor
tissue and specific blood cells and substances.

Lastly, researchers want to know if your genes (DNA) affect how your body
responds to the experimental medication or how your body breaks it down.
Scientists have identified a gene that is responsible for the production of a
receptor which is the target for the VTX-2337. This gene has a natural
variation that may possibly result in different responses to the experimental
drug in different patients. Your DNA sample, taken from your blood, will allow
researchers to determine which gene type is present in your body.

Hide details for General InformationGeneral Information

Disease Group:Fallopian Tube; Ovary; Peritoneum
Phase of Study:Phase II
Treatment Agents:Doxorubicin
VTX-2337
Treatment Location:Only at Other Sites
Estimated Length of Stay in Houston:
Supported By:Gynecologic Oncology Group
VentiRx Pharmaceuticals
VentiRx Pharmaceuticals
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Nicole Fleming
Dept:Gynecologic Oncology
For Clinical Trial Enrollment:281-566-1900
For General Questions about Clinical Trials:1-877-MDA-6789


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