Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Ovarian Carcinoma
  • Signal Transduction Pathway Deregulation
  • Therapy-Associated Cancer
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: on the basis of primary Signalling Transduction Pathway Activation 'targeted therapy' will be administered to ovarian carcinoma patientsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Only males

Description

Rationale: Ovarian carcinoma is one of the most lethal cancers in the world due to the fact that tumors are detected at late stage of disease, without curative therapies at that stage. Standard therapy consists of debulking surgery and platinum-paclitaxel containing chemotherapy. Despite this aggres...

Rationale: Ovarian carcinoma is one of the most lethal cancers in the world due to the fact that tumors are detected at late stage of disease, without curative therapies at that stage. Standard therapy consists of debulking surgery and platinum-paclitaxel containing chemotherapy. Despite this aggressive treatment five year survival is approximately 30%. Recently, it has been shown that tumor growth is driven by Signal Transduction Activation (STA) pathways. Twelve such pathways are known and in most tumours only one of these pathways is predominant. A number of "targeted therapy" drugs have become available, or are being developed that target individual STA pathways. Furthermore, a newly developed technique is able to assess which pathway is predominant in (ovarian) cancer. Therefore, specifically targeting the predominant pathway might impair tumor growth and might improve survival. Objective: This study aims to evaluate the effectiveness of targeted therapy, as defined by STA pathway analysis, in patients with recurrent ovarian carcinoma. Study design: Intervention study. Study population: Adult women with histologically/cytologically proven ovarian carcinoma who are group A: without symptoms and would normally await palliative chemotherapy until symptoms and group B: with symptoms, who are eligible for palliative chemotherapy. Intervention (if applicable): STA pathway analysis will be performed on histological biopsies taken from the tumor. Targeted drugs against the predominant pathway will be used against the predominant pathway. Initially we will start with targeted therapy in patients with either HH positive or ER positive tumors, since targeted therapy towards these pathways are easily available (itraconazole / tamoxifen) with little known side effects. For other targeted therapies approval will be asked separately. Main study parameters/endpoints: Response of tumour growth/regression.

Tracking Information

NCT #
NCT03458221
Collaborators
  • Radboud University
  • Erasmus Medical Center
Investigators
Not Provided