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A Randomized, Double-Blind, Placebo-Controlled Phase II Study Of Vtx-2337 In Combination With Pegylated Liposomal Doxorubicin (Pld) In Patients With Recurrent Or Persistent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer

Conditions

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.


Participation Guidelines

Age:
18 Years and older
Gender:
Female

Eligibility Criteria

Inclusion Criteria:

  1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  2. 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's tumor or adenocarcinoma not otherwise specified.
  3. Patient must have measurable disease as defined by RECIST 1.1.
  4. Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.

    Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease.

    Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of recurrent or persistent disease.

  5. Patients must have platinum-resistant disease, defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy.
  6. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions as defined by the following:

    • Bone marrow function: absolute neutrophil count (ANC) &ge 1,500/mm3. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets &ge 100,000/mm3. Hemoglobin &ge 9 g/dL.
    • Renal function: creatinine &le 1.5 x institutional upper limit normal (ULN).
    • Hepatic function: bilirubin < 1.2 mg/dL, SGOT (AST) and SGPT (ALT) &le 3.0 x ULN and alkaline phosphatase &le 2.5 x ULN.
  7. Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy:

    • Patients should be free of active infection requiring parenteral antibiotics.
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
    • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents, must be discontinued at least three weeks prior to registration.
    • Any prior radiation therapy must be completed at least four weeks prior to registration.
  8. Patients must have a GOG performance status of 0 or 1.
  9. Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
  10. Patients must meet the entry requirements and undergo the baseline procedures.
  11. Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information.
Sponsor:
Gynecologic Oncology Group
Dates:
09/12/2013
Last Updated:
Study HIC#:
1307012429