Suspended

Pegylated Liposomal Doxorubicin Combinations for Platinum Resistant Ovarian Cancer

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Study Aim

The study aims to assess the safety, effectiveness, and survival outcomes of pegylated liposomal doxorubicin in combination therapies for women with platinum-resistant ovarian cancer.

What is being tested

Atezolizumab

+ Computed Tomography

+ Pegylated Liposomal Doxorubicin Hydrochloride

DrugProcedureOtherBiological
Who is being recruted

Urogenital Diseases+14

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+51 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: June 2017
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 23, 2017

Actual date on which the first participant was enrolled.

This clinical trial explores new treatment options for individuals with platinum-resistant ovarian cancer, a type of cancer that does not respond to standard platinum-based chemotherapy. The study aims to test the safety and effectiveness of different combinations of drugs, including pegylated liposomal doxorubicin, atezolizumab, and bevacizumab. These drugs are being tested to see if they can improve the length of time patients live without the cancer getting worse and to understand if they can extend overall survival. This research is important as it seeks to find more effective treatments for patients who have limited options due to their resistance to conventional therapy. Participants in this study are divided into three groups, each receiving different combinations of the drugs administered intravenously (through an IV). The treatments are given in cycles, with each cycle repeating every 28 days unless there is disease progression or unacceptable side effects. The study measures how long patients live without their cancer worsening and tracks overall survival rates. It also looks at the safety of the drug combinations and records any side effects experienced by patients. Throughout the trial, participants undergo regular CT scans to monitor their condition. After completing the treatment, patients are followed up periodically for up to five years to assess long-term outcomes.

Official TitleA Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin, CTEP-Supplied Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin and CTEP-Supplied Bevacizumab in Platinum Resistant Ovarian Cancer
NCT02839707
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

444 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFallopian Tube DiseasesFallopian Tube NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

19 inclusion criteria required to participate
Platelets \>= 100,000/mcl (within 14 days prior to registration)

Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to registration)

Thyroid-stimulating hormone (TSH) within normal limits (Euthyroid patients on thyroid replacement therapy allowed provided TSH \< ULN) (02/20/2019)

Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up

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32 exclusion criteria prevent from participating
Patients with active tuberculosis (TB) are excluded

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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 and atezolizumab IV over 30-60 minutes on days 1 and 15. (Closed to accrual as of February 09, 2021)

Group II

Experimental
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. Patients also undergo CT on study.

Group III

Active Comparator
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. Patients also undergo CT on study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 922 locations

Suspended

Anchorage Radiation Therapy Center

Anchorage, United StatesOpen Anchorage Radiation Therapy Center in Google Maps
Suspended

Anchorage Associates in Radiation Medicine

Anchorage, United States
Suspended

Alaska Breast Care and Surgery LLC

Anchorage, United States
Suspended

Alaska Oncology and Hematology LLC

Anchorage, United States
Suspended922 Study Centers