Ovarian NeoplasmsNCT02861872
Intra-peritoneal Chemotherapy in Ovarian Cancer
An observational study of Ovarian Neoplasms and Immune Tolerance, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Neoplasms, Immune Tolerance, Neoplasms
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 9Show fewer
- Previous chemotherapy for ovarian carcinoma;
- Symptomatic hearing loss;
- Age >70 years.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, 6500HB
Mark Rietveld, M.D. MSc., +31243610353, mark.rietveld@radboudumc.nl
Peter van Essen, MSc., +31243610353, peter.vanessen@radboudumc.nl
About this study
Official title: Predictive Factors and Pharmacokinetics of Intra-peritoneal Chemotherapy
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.
- Keywords
- Ovarian, Ovarian cancer, Chemotherapy, Intraperitoneal chemotherapy, pharmacokinetics
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in tumor cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Primary pharmacokinetic endpoint: study pharmacokinetics of cisplatin (platinum unbound fraction) when administered in the IP cavity in plasma and in the peritoneal fluid.
Measured: Change in platinum unbound fraction of cisplatin during the first course (first three weeks) of chemotherapy.
Primary pharmacokinetic endpoint: study pharmacokinetics of paclitaxel (plasma concentrations) when administered in the IP cavity in plasma and in the peritoneal fluid.
Measured: Change in plasma concentration of paclitaxel during the first course (first three weeks) of chemotherapy.
Secondary outcomes (11)
Secondary immunological endpoint: rise in dendritic cells
Measured: Change in dendritic cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: rise in tumor infiltrating lymphocytes
Measured: Change in lymphocyte cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: rise in natural killer cells
Measured: Change in natural killer cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherpy during 18 weeks
Secondary immunological endpoint: decrease in macrophages M1 type
Measured: Change in macrophages M1 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: decrease in macrophages M2 type
Measured: Change in macrophages M2 type cell counts between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: change in cytokine level (IL-6) measured by ELISA
Measured: Change in IL-6 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: change in cytokine level (IL-10) measured by ELISA
Measured: Change in IL-10 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: change in cytokine level (IFNg) measured by ELISA
Measured: Change in IFNg cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: change in cytokine level (TNFa) measured by ELISA
Measured: Change in TNFa cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Secondary immunological endpoint: change in cytokine level (CCL2) measured by ELISA
Measured: Change in CCL2 cytokine levels between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
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.
Measured: Change in pSTAT between samples 15 min before and after administration of chemotherapy through completion of chemotherapy during 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelleke Ottevanger, M.D. PhD., Study chair, Internist-oncologist and principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861872
- Sponsor's protocol ID
- MOGYN16IP
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
PubMed 16394300Tewari D, Java JJ, Salani R, Armstrong DK, Markman M, Herzog T, Monk BJ, Chan JK. Long-term survival advantage and prognostic factors associated with intraperitoneal chemotherapy treatment in advanced ovarian cancer: a gynecologic oncology group study. J Clin Oncol. 2015 May 1;33(13):1460-6. doi: 10.1200/JCO.2014.55.9898. Epub 2015 Mar 23.
PubMed 25800756Schlappe BA, Mueller JJ, Zivanovic O, Gardner GJ, Long Roche K, Sonoda Y, Chi DS, O'Cearbhaill RE. Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center. Gynecol Oncol. 2016 Jul;142(1):13-18. doi: 10.1016/j.ygyno.2016.05.015. Epub 2016 May 21.
PubMed 27189456Wright JD, Hou JY, Burke WM, Tergas AI, Chen L, Hu JC, Ananth CV, Neugut AI, Hershman DL. Utilization and Toxicity of Alternative Delivery Methods of Adjuvant Chemotherapy for Ovarian Cancer. Obstet Gynecol. 2016 Jun;127(6):985-991. doi: 10.1097/AOG.0000000000001436.
PubMed 27159764de Jong LAW, Lambert M, van Erp NP, de Vries L, Chatelut E, Ottevanger PB. Systemic exposure to cisplatin and paclitaxel after intraperitoneal chemotherapy in ovarian cancer. Cancer Chemother Pharmacol. 2023 Mar;91(3):247-256. doi: 10.1007/s00280-023-04512-z. Epub 2023 Mar 9.
PubMed 36892677
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Pharmacokinetics of Intra-peritoneal Chemotherapy
- ClinicalTrials.gov ID
- NCT02861872
- Acronym / sponsor ID
- MOGYN16IP
- Keywords
- Ovarian, Ovarian cancer, Chemotherapy, Intraperitoneal chemotherapy, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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))
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Background: PubMed 16394300Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
- Background: PubMed 25800756Tewari D, Java JJ, Salani R, Armstrong DK, Markman M, Herzog T, Monk BJ, Chan JK. Long-term survival advantage and prognostic factors associated with intraperitoneal chemotherapy treatment in advanced ovarian cancer: a gynecologic oncology group study. J Clin Oncol. 2015 May 1;33(13):1460-6. doi: 10.1200/JCO.2014.55.9898. Epub 2015 Mar 23.
- Background: PubMed 27189456Schlappe BA, Mueller JJ, Zivanovic O, Gardner GJ, Long Roche K, Sonoda Y, Chi DS, O'Cearbhaill RE. Cited rationale for variance in the use of primary intraperitoneal chemotherapy following optimal cytoreduction for stage III ovarian carcinoma at a high intraperitoneal chemotherapy utilization center. Gynecol Oncol. 2016 Jul;142(1):13-18. doi: 10.1016/j.ygyno.2016.05.015. Epub 2016 May 21.
- Background: PubMed 27159764Wright JD, Hou JY, Burke WM, Tergas AI, Chen L, Hu JC, Ananth CV, Neugut AI, Hershman DL. Utilization and Toxicity of Alternative Delivery Methods of Adjuvant Chemotherapy for Ovarian Cancer. Obstet Gynecol. 2016 Jun;127(6):985-991. doi: 10.1097/AOG.0000000000001436.
- Derived from this study: PubMed 36892677de Jong LAW, Lambert M, van Erp NP, de Vries L, Chatelut E, Ottevanger PB. Systemic exposure to cisplatin and paclitaxel after intraperitoneal chemotherapy in ovarian cancer. Cancer Chemother Pharmacol. 2023 Mar;91(3):247-256. doi: 10.1007/s00280-023-04512-z. Epub 2023 Mar 9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelleke Ottevanger, M.D. PhD. study chair
Internist-oncologist and principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Immune Tolerance, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Rietveld, M.D. MSc. (+31243610353, mark.rietveld@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861872, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.