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
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
4 other identifiers
interventional
20
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedDecember 25, 2014
December 1, 2014
3.3 years
February 10, 2011
December 23, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
First-cycle dose-limiting toxicities
28 days
Frequency and severity of toxicities as assessed by CTCAE
Up to 1 year
Secondary Outcomes (4)
Immune activation (e.g., Th1, cytokines)
Up to 1 year
Pharmacokinetic measures of TLR8 agonist VTX-2337
Baseline, 0.5, 2, 4, 8, and 24 hours after TLR8 agonist VTX-2337 injection
Pharmacokinetic measures of pegylated liposomal doxorubicin hydrochloride
Baseline, 0.5, 2, 4, 8, and 24 hours after TLR8 agonist VTX-2337 injection
Pharmacokinetic measures of paclitaxel
Baseline, 0.5, 2, 4, 8, and 24 hours after TLR8 agonist VTX-2337 injection
Study Arms (1)
Treatment (TLR8 agonist VTX-2337, PLD, and Paclitaxel)
EXPERIMENTALPatients receive TLR8 agonist VTX-2337 SC on days 3, 10, and 17 and pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 or TLR8 agonist VTX-2337 SC 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.
Interventions
Given SC
Correlative studies
Correlative studies
Given IV
Given IV
Eligibility Criteria
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)
- +60 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (10)
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, 85012, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Monk
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2014
Last Updated
December 25, 2014
Record last verified: 2014-12