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Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase II Trial of Irinotecan Liposome and Bevacizumab in Women With Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04753216•Northwestern University

View on ClinicalTrials.gov

Summary

This phase II trial investigates the effect of irinotecan liposome and bevacizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that shows less response to platinum therapy (platinum resistant), has come back (recurrent), or does not respond to treatment (refractory). Irinotecan liposome may help block the formation of growths that may become cancer. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving irinotecan liposome and bevacizumab may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVE: I. To assess the antineoplastic efficacy of irinotecan sucrosofate (irinotecan liposome) in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer, as measured by the objective response rate (ORR). SECONDARY EFFICACY OBJECTIVES: I. To determine the overall best response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in women with recurrent, platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab. II. To determine the clinical benefit rate (CBR) for irinotecan liposome in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer. III. To calculate the duration of response (DOR) for irinotecan liposome in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer. IV. To calculate the duration of stable disease (duration of SD) for irinotecan liposome in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer. V. To calculate the time to response (TTR) for irinotecan liposome in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer. VI. To measure median progression-free survival (PFS) in women with recurrent, platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab. VII. To measure 16 week progression-free survival (PFS-16) in women with recurrent, platinum resistant ovarian cancer who have received treatment with irinotecan liposome in combination with bevacizumab. SECONDARY SAFETY OBJECTIVE: I. To assess the toxicity profile of irinotecan liposome in combination with bevacizumab in women with recurrent, platinum resistant ovarian cancer according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. OUTLINE: Patients receive bevacizumab intravenously (IV) and irinotecan sucrosofate IV over 90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months for 2 years.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Subjects must have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
•Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial are eligible
•Subjects with a known history severe cardiac disease, current symptoms of cardiac disease (e.g., unstable angina pectoris or cardiac arrhythmia), or a history of treatment with cardiotoxic agents should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, these subjects must be class 2B or better
•For subjects with hypertension, hypertension must be well controlled on medication.
•* NOTE: Uncontrolled hypertension is defined as a consistent blood pressure (bp) of \>= 160 mmHg systolic or \>= 100 mmHg diastolic, on initial and repeat checks
•Females of reproductive potential must agree to undergo a urine or serum pregnancy test, and the results must be negative in order to initiate treatment.
•* NOTE: A female of reproductive potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
•* Has not undergone a hysterectomy or bilateral oophorectomy
•* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
•Females of reproductive potential must agree to use adequate contraception (abstinence or two methods of birth control, such as a barrier method in combination with hormonal contraception) while receiving trial therapy and for 6 months following completion of trial therapy. Should a woman become pregnant or suspect she is pregnant while is participating in this study, she should inform her treating physician immediately.
+7 more criteria

Exclusion Criteria

•Subjects must have recurrent, platinum resistant or refractory disease, defined as progression \< 6 months after completion of a platinum-based chemotherapy regimen or as persistent disease that remains after completion of a platinum-based therapy
•Subjects must have measurable disease as assessed by RECIST 1.1
•Subjects must have received at least 1 but no more than 3 prior platinum-based chemotherapy regimens
•Subjects must have adequately recovered (in the opinion of the treating investigator) from adverse events due to prior anti-cancer therapy, with the exceptions of any grade alopecia and =\< grade 2 peripheral neuropathy per NCI-CTCAE version 5.0
•Subjects must be age \>= 18 years
•Subjects must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
•Hemoglobin \>= 9.0 g/dL (within =\< 28 days prior to registration)
•White blood cell (WBC) count \>= 3.0 x 10\^9/L (within =\< 28 days prior to registration)
•Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within =\< 28 days prior to registration)
•Platelet count \>= 75 x 10\^9/L (within =\< 28 days prior to registration)
+56 more criteria

Locations (1)

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

March 16, 2021

Primary Completion Date

August 31, 2021

Completion Date

October 25, 2021

Last Updated

January 19, 2023

Enrollment

ACTUAL participants

Conditions

Platinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRefractory Fallopian Tube CarcinomaRefractory Ovarian CarcinomaRefractory Primary Peritoneal Carcinoma

Interventions

Bevacizumab

BIOLOGICAL

Irinotecan Sucrosofate

DRUG

Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.

NCT05271318

Platinum-refractory Ovarian CarcinomaPlatinum-resistant Ovarian Cancer+7 more

View study

RECRUITINGPHASE2

Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

NCT05998135

Ovarian High Grade Serous AdenocarcinomaPlatinum-Resistant Ovarian Carcinoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Irinotecan Liposome and Bevacizumab for the Treatment of Platinum Resistant, Recurrent, or Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

Exclusion Criteria

Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer.

Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

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P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors