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Signal Transduction Analysis in OVarian cancER (STAPOVER)

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ClinicalTrials.gov Identifier: NCT03458221
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Radboud University
Erasmus Medical Center
Information provided by (Responsible Party):
Jurgen M.J. Piek, Catharina Ziekenhuis Eindhoven

Brief Summary:

PROBLEM DEFINITION/OBJECTIVE: Ovarian cancer is the 5th most lethal cancer in the world due to the fact that tumours are detected at late stage of disease, currently without curative therapies at that stage. Standard therapy consists of surgery and chemotherapy. Despite this aggressive treatment overall five year survival is only 30%. Tumors are driven by cellular signal transduction (ST) pathways. Identifying activity of these pathways in cancer tissue can be used to choose an appropriate targeted drug. A number of targeted therapy drugs have become available, or are being developed that target individual ST pathways. Identification of the predominant ST pathway in cancer has shown to be extremely difficult. A newly developed reliable mRNA analysis technique (STAnalysis) is able to assess which pathway/s is/are active indicating which targeted therapy is deemed to be effective.

STUDY DESIGN: A multicentre prospective cohort study. STUDY POPULATION: Patients with platinum-refractory/resistant or recurrent ovarian cancer.

DIAGNOSTIC INTERVENTION & COMPARATOR: Analysis of the prevalent ST pathway and targeted therapy towards this pathway.

OUTCOME MEASURES: Increase in survival.


Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Signal Transduction Pathway Deregulation Therapy-Associated Cancer Drug: Itraconazole Phase 3

Detailed 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: on the basis of primary Signalling Transduction Pathway Activation 'targeted therapy' will be administered to ovarian carcinoma patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Signal Transduction Analysis in OVarian cancER
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Experimental: itraconazole / tamoxifen
In case of HedgeHog pathway positivity itraconazole will be administered in case of ER pathway positivity tamoxifen will be adminisered
Drug: Itraconazole
based on the predominant Signal transduction pathway analysis 'targeted therapy' will be administered
Other Name: tamoxifen



Primary Outcome Measures :
  1. survival benefit [ Time Frame: 4 months or more ]
    months gained by adding 'targeted therapy' drugs


Secondary Outcome Measures :
  1. QOL [ Time Frame: pre treatment and 1, 3, 4 and 6 months after treatment start ]
    quality of Life in the group of patients treated with 'targeted therapy' by EORTC QLQ-C30 questinaire



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   ovarian cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, age > 18 years
  • Proven recurrence of FIGO stage III-IV ovarian carcinoma
  • Ability and willingness to provide written and oral consent
  • Able to speak and understand Dutch
  • Physical condition WHO 0 or I

Exclusion Criteria:

  • Age < 18 years
  • Final diagnosis not ovarian carcinoma
  • Chemotherapy naive
  • Unable or unwilling to provide informed consent
  • Enrolled in hospice or palliative care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458221


Contacts
Contact: Jurgen M Piek, MD, PhD +31(0)40 239 91 11 jurgen.piek@catharinaziekenhuis.nl
Contact: Ruud Bekkers, MD, PhD +31(0)40 239 91 11 ruud.bekkers@catharinaziekenhuis.nl

Locations
Netherlands
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Brabant, Netherlands, 5623EJ
Contact: Jurgen M Piek, MD. PhD.    +31(0)40 239 9111    jurgen.piek@catharinaziekenhuis.nl   
Radboudumc Not yet recruiting
Nijmegen, Gelderland, Netherlands
Contact: L Massuger, Prof       l.massuger@obgyn.umcn.nl   
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: I Boere, MD., PhD.       i.boere@erasmusmc.nl   
Sponsors and Collaborators
Gynaecologisch Oncologisch Centrum Zuid
Radboud University
Erasmus Medical Center

Responsible Party: Jurgen M.J. Piek, MD, PhD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT03458221     History of Changes
Other Study ID Numbers: STAPOVER
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jurgen M.J. Piek, Catharina Ziekenhuis Eindhoven:
ovarian carcinoma
Signal Transduction Pathway
therapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Second Primary
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Tamoxifen
Itraconazole
Hydroxyitraconazole
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action