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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

Status
Closed
Cancer Type
Ovarian Cancer
Trial Phase
Phase II
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT02839707
Protocol IDs
NRG-GY009 (primary)
NRG-GY009
NCI-2016-01081
NRG-GY009
Study Sponsor
NRG Oncology

Summary

This randomized 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. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. block tumor growth Monoclonal antibodies, such as atezolizumab and bevacizumab, 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.

Objectives

PRIMARY OBJECTIVES:
I. Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (pegylated liposomal doxorubicin hydrochloride [pegylated liposomal doxorubicin] [PLD] and atezolizumab and PLD/bevacizumab and atezolizumab). (Safety lead-in)
II. Estimate and compare the hazard of first progression or death (progression free survival [PFS]) of each experimental regimen relative to the reference regimen, PLD and bevacizumab. (Phase II study)
III. Estimate and compare the hazard of death and the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen. (Phase III)

SECONDARY OBJECTIVES:
I. Estimate and compare the probabilities of response rate (objective response rate [ORR], either partial or complete response) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria on each study regimen. (Phase II study)
II. Estimate the frequency and severity of adverse events as classified and graded with Common Terminology Criteria for Adverse Events (CTCAE) v.4.0 in those patients who initiate their randomly assigned study treatment. (Phase II study)
III. Estimate and compare ORR in each treatment group. (Phase III study)
IV. Estimate the frequency and severity of adverse events in those patients who initiate their randomly assigned study treatment. (Phase III study)
V. Estimate and compare mean patient reported outcome scores (PROs) as measured by National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) ovarian symptom index (NFOSI)-18 disease-related symptoms (DRS). (Phase III study)
VI. Estimate and compare the treatment groups on the basis of the PROs: treatment side effects (TSE), function/well-being (FWB), fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-fatigue [F] subscale) and abdominal discomfort (FACT/Gynecologic Oncology Group [GOG]-abdominal discomfort [AD] subscale). (Phase III study)

TERTIARY OBJECTIVES:
I. To determine whether biomarker levels in pre-treatment tissue, and pre- or on-treatment peripheral blood, and stool specimens are associated with ORR, PFS and/or overall survival (OS).
II. To determine whether changes in quantitative biomarker parameters after the first 6 and 12 weeks of therapy predict ORR, PFS and/or OS.

OUTLINE: Patients will be randomized to 1 of 3 arms.

ARM I: Patients receive pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15.

ARM II: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and atezolizumab IV over 30-60 minutes on days 1 and 15.

ARM III: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15.

In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 2 years, then every 6 months for up to 3 years.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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