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A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer
Overall Recruitment Status: Enrollment complete
 
Official Title
A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym NCT No.
NCT02839707
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
This phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent). Chemotherapy drugs, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Administration of study drugs (pegylated liposomal doxorubicin, bevacizumab, atezolizumab) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality
  • women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control
  • abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent
  • should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. (06/29/2017)
  • Submission of tumor tissue is required for all patients
  • investigators should check with their site pathology department regarding release of biospecimens before approaching patients about participation in the trial
  • High grade ovarian cancer, including high grade serous
  • clear cell
  • endometrioid, grade 3
  • and others (adenocarcinoma, not otherwise specified [NOS]
  • mixed epithelial carcinoma
  • undifferentiated carcinoma)
  • NOTE: low grade serous, mucinous and carcinosarcoma histologies are excluded due to their different underlying genomic features and/or clinical behavior
  • ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer
  • required data element: submission of pathology report
  • Recurrent, platinum resistant ovarian cancer (defined as progression within < 6 months from completion of platinum based therapy
  • the date should be calculated from the last administered dose of platinum therapy)
 
Exclusion Criteria
  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Patients who have had systemic anticancer therapy (e.g., chemotherapy, targeted therapy including PARP inhibitors or bevacizumab) within 3 weeks prior to entering the study (30-OCT-2020)
  • Patients who have had hormonal therapy (e.g., tamoxifen, aromatase inhibitor) within 1 week prior to entering the study
  • Patients with prior treatment with anti-programmed cell death (PD)-1, anti- programmed cell death ligand (PD-L)1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 therapeutic antibody or other similar agents (10/16/2017)
  • Patients with prior treatment with bevacizumab (or any other anti vascular therapy, e.g., cediranib) for platinum resistant recurrence
  • (Note: prior bevacizumab in initial therapy and/or platinum sensitive recurrent setting is allowed) (10/16/2017)
 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Alex Menter
Contact Information:
- CTP Team
-ctpcollaborate@kp.org
-Lone Tree Medical Offices - Lone Tree


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