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Intra-peritoneal Chemotherapy in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861872
Recruitment Status : Unknown
Verified July 2016 by Radboud University.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
Ovarian cancer is the third most common gynecological malignancy worldwide. Because of late, aspecific symptoms, the disease is usually diagnosed at an advanced stage. Most patients experience recurrence and die as a result of the disease within 5 years. Treatment is a combination of surgical debulking and systemic administered chemotherapy. Intra-peritoneal (IP) chemotherapy with is currently considered the most effective treatment. In patients with at least an optimal surgical debulking, this leads to an improvement in life expectancy from 50 to 66 months. IP administration of chemotherapeutic agents is still not common practice. Furthermore recent studies revealed that cancer cells express a variety of tumor antigens, which can be targeted by the immune system. Also ovarian cancer shows evidence of a role for the immune system in clinical outcome. Novel insights into the mechanism of action of chemotherapy indicate that the efficacy of chemotherapeutic interventions are dependent on the modulation of the immune system. The impression exists that since IP chemotherapy is used, relatively more recurrences outside the abdominal cavity are observed. As of yet, no studies have described pharmacokinetics and pharmacodynamics of IP administered cisplatin and paclitaxel in the blood circulation. The investigators propose to study the use of this aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, monitor the effect of chemotherapy on IP tumor cells in the peritoneal cavity and monitor the effect of chemotherapy on immune cells present in the IP cavity. As well the investigators propose to correlate the presence and amount of tumor cells in peritoneal fluid with the debulking efficacy and CA 125 levels. Secondary to this the investigators intend to determine the pharmacokinetics of cisplatin and paclitaxel when administered in the IP cavity in the central circulation (plasma) as well as in the peritoneal fluid. In this observational explorative study women, aged younger than 70 years, who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and biochemical state to receive chemotherapy are included. Immunological cell counts, tumor marker, immunological cell pathway activation and plasma concentrations of cisplatinum and paclitaxel in venous blood and in fluid aspirated from the abdominal cavity will be measured.

Condition or disease
Ovarian Neoplasms Immune Tolerance Neoplasms Effects of Chemotherapy

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors and Pharmacokinetics of Intra-peritoneal Chemotherapy
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort
IP Patients
women, aged younger than 70 years, who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and biochemical state to receive chemotherapy will be studied.



Primary Outcome Measures :
  1. Primary immunological endpoint: study the use of aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, measured by decrease in tumor cell count in IP fluid. [ Time Frame: Change in tumor cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  2. Primary pharmacokinetic endpoint: study pharmacokinetics of cisplatin (platinum unbound fraction) when administered in the IP cavity in plasma and in the peritoneal fluid. [ Time Frame: Change in platinum unbound fraction of cisplatin during the first course (first three weeks) of chemotherapy. ]
  3. Primary pharmacokinetic endpoint: study pharmacokinetics of paclitaxel (plasma concentrations) when administered in the IP cavity in plasma and in the peritoneal fluid. [ Time Frame: Change in plasma concentration of paclitaxel during the first course (first three weeks) of chemotherapy. ]

Secondary Outcome Measures :
  1. Secondary immunological endpoint: rise in dendritic cells [ Time Frame: Change in dendritic cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  2. Secondary immunological endpoint: rise in tumor infiltrating lymphocytes [ Time Frame: Change in lymphocyte cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  3. Secondary immunological endpoint: rise in natural killer cells [ Time Frame: Change in natural killer cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherpy during 18 weeks ]
  4. Secondary immunological endpoint: decrease in macrophages M1 type [ Time Frame: Change in macrophages M1 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  5. Secondary immunological endpoint: decrease in macrophages M2 type [ Time Frame: Change in macrophages M2 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  6. Secondary immunological endpoint: change in cytokine level (IL-6) measured by ELISA [ Time Frame: Change in IL-6 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  7. Secondary immunological endpoint: change in cytokine level (IL-10) measured by ELISA [ Time Frame: Change in IL-10 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  8. Secondary immunological endpoint: change in cytokine level (IFNg) measured by ELISA [ Time Frame: Change in IFNg cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  9. Secondary immunological endpoint: change in cytokine level (TNFa) measured by ELISA [ Time Frame: Change in TNFa cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  10. Secondary immunological endpoint: change in cytokine level (CCL2) measured by ELISA [ Time Frame: Change in CCL2 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]
  11. Primary immunological endpoint: study the use of aspiration fluid from the IP cavity as a biomarker for the efficacy of chemotherapy intervention, measured by decrease in pSTAT in IP fluid. [ Time Frame: Change in pSTAT between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks ]

Biospecimen Retention:   Samples Without DNA
EDTA blood and IP fluid


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women, aged younger than 70 years, who will receive standard IP chemotherapy for advanced epithelial ovarian cancer, who are in an adequate physical and biochemical state to receive chemotherapy.
Criteria

Inclusion Criteria:

Patients receiving IP chemotherapy and therefore meeting the following criteria:

  • Primary epithelial ovarian carcinoma FIGO stage III;
  • Optimal or complete primary debulking (tumor rests ≤ 1cm;
  • WHO 0 - 2;
  • Adequate hematological function: WBC ≥ 3. 106/L en Platelets ≥ 100. 106/L,
  • Adequate renal function (Creatinine clearance >60 ml/min (Cockcroft))
  • Adequate liver function tests (bilirubin and/or transaminases <1.25 UNL)

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study (according to the standard IP chemotherapy):

  • Intestinal stoma proximal to the flexura lienalis;
  • Postoperative sepsis after primary debulking;
  • Haemoglobin < 6.0 mMol/L
  • Extended intraperitoneal adhesions;
  • Neurotoxicity grade>1;
  • Previous chemotherapy for ovarian carcinoma;
  • Symptomatic hearing loss;
  • Age >70 years.

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): NCT02861872


Contacts
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Contact: Mark Rietveld, M.D. MSc. +31243610353 mark.rietveld@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Mark Rietveld, M.D. MSc.    +31243610353    mark.rietveld@radboudumc.nl   
Contact: Peter van Essen, MSc.    +31243610353    peter.vanessen@radboudumc.nl   
Principal Investigator: Nelleke Ottevanger, M.D. PhD.         
Sponsors and Collaborators
Radboud University
Investigators
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Study Chair: Nelleke Ottevanger, M.D. PhD. Internist-oncologist and principal investigator
Publications:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02861872    
Other Study ID Numbers: MOGYN16IP
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Radboud University:
Ovarian
Ovarian cancer
Chemotherapy
Intraperitoneal chemotherapy
pharmacokinetics
Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders