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Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer

Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.

NCT01637532•Leiden University Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron). This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Histologically proven epithelial ovarian cancer
•Progression of disease or relapse after previous therapy with platinum
•Measurable disease (RECIST 1.1) or elevated CA125 \> 2 times the upper normal limit (UNL) within 3 months and confirmed
•Age ≥18 years
•WHO performance status 0-2
•Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
•Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT
•* 2.5 x UNL (\<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
•Adequate renal function: the calculated creatinine clearance should be
•* 50 mL/min
+3 more criteria

Exclusion Criteria

•Chemotherapy within past 3 months
•Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
•Known hypersensitivity reaction to any of the components of the treatment
•Pregnancy or lactating
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
•Infection with tuberculosis and hepatitis B or C

Locations (1)

Leiden University Medical Center

Leiden, Netherlands

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

January 26, 2016

Enrollment

ACTUAL participants

Conditions

Recurrent Ovarian Cancer

Interventions

tocilizumab and interferon alpha 2-b

DRUG

Carboplatin and Caelyx or doxorubicin

DRUG

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

NCT05942300

Recurrent Ovarian Cancer

View study

ACTIVE_NOT_RECRUITINGPHASE2

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

NCT05335993

Recurrent Ovarian CancerRecurrent Epithelial Cancer of Ovary+5 more

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 26, 2016Data 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.

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Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer

A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors

Avastin Plus Chemotherapy vs. Avastin Plus Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Ovarian Cancer

Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients

The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab