Immune regulation and timing of chemotherapy in advanced/recurrent ovarian and endometrial cancer - TIREG

Phase 1

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10057529Term: Ovarian cancer metastatic; MedDRA version: 12.1Level: PTClassification code 10057529Term: Ovarian cancer metastatic; MedDRA version: 12.1Level: PTClassification code 10014734Term: Endometrial cancer metastatic; MedDRA version: 12.1Level: PTClassification code 10014736Term: Endometrial cancer recurrent; MedDRA version: 12.1Level: LLTClassification code 10014736Term: Endometrial cancer recurrent; MedDRA version: 12.1Level: PTClassification code 10066697Term: Ovarian cancer recurrent; advanced/recurrent ovarian and endometrial cancer; MedDRA version: 12.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent; MedDRA version: 12.1Level: LLTClassification code 10014734Term: Endometrial cancer metastatic

• Registration Number: EUCTR2010-023457-11-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-24
• Study Completion: 2012-02-08
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

-Failure of two lines of cytotoxic chemotherapy (ovarian cancer) or one line of cytotoxic chemotherapy (endometrial cancer)
-ECOG Status 1-2
-No previous chemotherapy for 3 months
-Confirmed histological evidence of either ovarian or primary peritoneal malignancy or endometrial cancer. All histological types will be included.
-Assessable disease by imaging (either CT Scan or MRI scan) will need to be present or alternatively, if absent, CA 125 levels should be at least twice normal and shown to have been increased on two occasions at least one week apart.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Documented autoimmune disease
-Currently ongoing systemic corticosteroid therapy and/or immune suppressant therapy
-Venous access is predicted to obviate frequent blood samples

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Immunomodulation by synchronizing the administration of cytotoxic agents to the phase of the repeating anti-tumour immune cycle;Secondary Objective: Is the repeating anti-tumour immune cycle correlated with the level of regulatory T cells or inflammatory mediators and can these be affected by timing the administration of cytotoxic agents to certain phases of the anti-tumour immune cycle?;Primary end point(s): Response rate according to GCIG criteria for CA125 response and RECIST criteria for imaging response