TLR8 Agonist VTX-2337 and Pegylated Liposomal Doxorubicin Hydrochloride or Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

Completed · Phase 1

Conditions studied: Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Cystadenocarcinoma, Ovarian Serous Cystadenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Undifferentiated Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT01294293

Run by

Gynecologic Oncology Group

People needed

20

Starts

2011-03-01

Last updated by the study team

2014-12-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
• Histologic documentation of the original primary tumor is required via the pathology report
• Patients with the following histologic cell types are eligible:
• Serous adenocarcinoma
• Endometrioid adenocarcinoma
• Mucinous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial adenocarcinoma
• Transitional cell carcinoma
• Malignant Brenner tumor
• Adenocarcinoma not otherwise specified (N.O.S.)
• Patient must have measurable disease or detectable (non-measurable) disease:
• Measurable disease will be defined by RECIST 1.1
• Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded)
• Each lesion must be ≥ 10 mm when measured by CT, MRI, or caliper measurement by clinical exam or ≥ 20 mm when measured by chest x-ray
• Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI
• Detectable (non-measurable) disease is defined as not having measurable disease but has at least one of the following conditions:
• Baseline values of CA-125 ≥ 2 x ULN
• Patients whose CA-125 is < 100 U/mL must undergo a second confirmatory value within a period of ≤ 4 weeks
• Patients with a level ≥ 100 U/mL may be entered without confirmatory measurement
• The CA-125 assessment for eligibility must be done at least 4 weeks after paracentesis or other surgical procedures
• Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
• Patient with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1
• Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

Where it is running

• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.