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Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin (ISOTOVE)

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intraperitoneal cisplatin with nanocis
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, intraperitoneal chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Performance Status 0-2
  • PNN> 1.5.109 / L (without added GCSF)
  • Plaquettes> 100. 109 / L
  • Bilirubine inferior or equal to 1.5 times the upper normal value (VNS)
  • ASAT And ALT inferior or equal to 2.5 upper normal value (VNS)
  • Alkaline Phosphatase inferior or equal to2.5 upper normal value (VNS)
  • Clairance Creatinine> 60ml / min Normal -Ionogramme
  • PTT <1.5 times the upper normal value (VNS) (heparin, or other accepted lovenox anticoagulants)
  • PT / INR inferior or equal to 1.5 upper normal value (VNS) (or INR between 2 and 3, if the patient receives a stabilized dose of Warfarin)
  • Patient operated first line without macroscopic residual for ovarian cancer or primary peritoneal or tubal stage IIIC or IV peritoneal pleural
  • Minimum Required for surgery: hysterectomy, oophorectomy, pelvic lymphadenectomy and para-aortic omentectomy
  • Patient requiring adjuvant chemotherapy
  • Compulsory affiliation to a social security scheme.
  • Obtaining informed consent in writing, signed and dated.

Exclusion Criteria:

  • Patient with cognitive and psychiatric disorders.
  • Patient deprived of liberty by a court or administrative.
  • Patient having directions against the achievement of chemotherapy
  • Concomitant treatment with a drug test, participation in another therapeutic clinical trial within 30 days
  • Pregnant women
  • Nursing women
  • Patient with recognized hypersensitivity to cisplatin or platinum-containing products
  • Patient with hypersensitivity recognized paclitaxel or any of the excipients
  • Patient must be vaccinated against yellow fever
  • Patient before taking phenytoin for prophylactic purposes
  • Patient with hearing impairment
  • Patient with hepatic impairment
  • Patient with renal impairment Sensory or motor -Neuropathies> grade 1 (CTCAE)
  • Hépatite Or severe infection requiring parenteral antibiotics
  • Serious non-healing wound or ulcer, or bone fracture
  • Fistule Abdominal or gastrointestinal perforation, or intra-abdominal abscess in the 28 days preceding the intraperitoneal chemotherapy Clinical -Symptômes, gastrointestinal obstruction or signs and / or which require a hydration and / or parenteral nutrition
  • Patientes Has had or currently with inflammatory bowel disease
  • Active bleeding or medical condition that carries a high risk of bleeding (eg, known coagulation disorders, coagulopathy, or tumor with large vessels)
  • Cerebrovascular accident (CVA) or transient ischemic attack, or subarachnoid hemorrhage in the last 6 months

  • Disease clinically significant cardiovascular, including:

    • uncontrolled hypertension, defined as systolic blood pressure> 150mmHg or diastolic> 90mmHg
    • myocardial infarction or unstable angina within the last 6 months
    • NYHA class II-IV congestive heart failure
    • serious cardiac arrhythmia requiring treatment: -an asymptomatic atrial fibrillation with controlled ventricular rate supraventricular tachycardia or controlled with medication and is authorized asymptomatic peripheral vascular disease o ≥ Grade 2 (CTCAE) (brief [less than 24 hours] ischemia episodes managed non-surgically and without permanent deficit)
  • Antecedents of Hemorrhage or stroke (stroke), transient ischemic attack, or subarachnoid in the last 6 months Major Surgery within 28 days prior to inclusion

Sites / Locations

  • Centre Jean Perrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy

Outcomes

Primary Outcome Measures

Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity
The intensity of fixation will be defined as followed: 0: no fixation fixation of low intensity fixation of high intensity

Secondary Outcome Measures

Note adverse events assessed with CTCAE v4.0
The treatment-related adverse events will be assessed with CTCAE v4.0
Correlate pain intensity to fixation intensity in the peritoneal cavity
Pain intensity will be measured with EVA scale
dosimetric study with peritoneal scintigraphy
This study will be realised only for the first three patients included in the trial
Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity

Full Information

First Posted
January 19, 2016
Last Updated
October 10, 2016
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT02667925
Brief Title
Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
Acronym
ISOTOVE
Official Title
Study of the Isotopic Distribution of Intraperitoneal Postoperative Locoregional Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Because of the obsolescence of the study
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor. A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009). However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%. To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally. The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity. Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival. Armstrong shows in addition a decreased risk of recurrence. It must be remembered that: The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions). There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy. Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.
Detailed Description
Epithelial ovarian cancer is the fifth leading cause of female cancer and the leading cause of death among gynecological cancers (Alberts et al, 2002). The treatment of advanced ovarian cancer is based on the combination of chemotherapy based on platinum salt and surgery whose quality is the major prognostic factor. A meta-analysis of retrospective series had shown that for every 10% increase in the complete cytoreduction rates were increased by 5.5% overall survival time (Markman et al, 2001). Currently, it is recognized that the best chance of survival conferred to patients whose initial surgical residue is zero (Harter et al, 2009). However, even if macroscopically complete surgery and whatever the type of systemic chemotherapy, peritoneal recurrence remains high for more than 75%. To reducing it of recurrence, a therapeutic approach is to administer chemotherapy intraperitoneally. The intraperitoneal chemotherapy consists to administer the drug directly into the peritoneal cavity at a frequency that is related to systemic chemotherapy (every 3 weeks). Alberts et al, 1996 and Armstrong et al, 2006 compared the efficacy in terms of survival of an intraperitoneal chemotherapy according to this method with a conventional systemic chemotherapy. Alberts reported a significant improvement in the median overall survival (49 vs 41 months). Armstrong shows in addition a decreased risk of recurrence. It must be remembered that: The establishment of an intra-abdominal catheter does not always ensure complete flow of drugs into the peritoneal cavity (major postoperative adhesions). There may be problems of catheters becoming blocked and requiring local treatment; these problems can cause abdominal pain whose care is difficult. Thus almost half of patients fail to get all six courses of intraperitoneal chemotherapy. Thus, the investigators propose to estimate the flow of intraperitoneal chemotherapy with IP peritoneal scintigraphy, using a radiotracer (nanocis®). The investigators hypothesize that the movement of colloids in peritoneal cavity is similar to the circulation of chemotherapy within the peritoneal cavity (From Forni et al, 1993, Varia et al, 2003, Young et al, 2003, Dawson et al, 2011). The accumulation of radiotracer will be more correlated with abdominal pain sites described by the patient as well as peritoneal recurrence sites found during monitoring.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, intraperitoneal chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Patients will receive an intraperitoneal chemotherapy (cisplatin) combined to a radiotracer (nanocis) in order to assess the intraperitoneal distribution of the chemotherapy
Intervention Type
Drug
Intervention Name(s)
Intraperitoneal cisplatin with nanocis
Intervention Description
Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy
Primary Outcome Measure Information:
Title
Quantification by visual analysis the intensity of fixation of the solvent characterized in the intraperitoneal cavity
Description
The intensity of fixation will be defined as followed: 0: no fixation fixation of low intensity fixation of high intensity
Time Frame
During the 6 cycles of chemotherapy, that is during 18 weeks
Secondary Outcome Measure Information:
Title
Note adverse events assessed with CTCAE v4.0
Description
The treatment-related adverse events will be assessed with CTCAE v4.0
Time Frame
During the 6 cycles of chemotherapy, that is during 18 weeks
Title
Correlate pain intensity to fixation intensity in the peritoneal cavity
Description
Pain intensity will be measured with EVA scale
Time Frame
During the 6 cycles of chemotherapy, that is during 18 weeks
Title
dosimetric study with peritoneal scintigraphy
Description
This study will be realised only for the first three patients included in the trial
Time Frame
During the 6 cycles of chemotherapy, that is during 18 weeks
Title
Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity
Time Frame
During 5 years after chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Performance Status 0-2 PNN> 1.5.109 / L (without added GCSF) Plaquettes> 100. 109 / L Bilirubine inferior or equal to 1.5 times the upper normal value (VNS) ASAT And ALT inferior or equal to 2.5 upper normal value (VNS) Alkaline Phosphatase inferior or equal to2.5 upper normal value (VNS) Clairance Creatinine> 60ml / min Normal -Ionogramme PTT <1.5 times the upper normal value (VNS) (heparin, or other accepted lovenox anticoagulants) PT / INR inferior or equal to 1.5 upper normal value (VNS) (or INR between 2 and 3, if the patient receives a stabilized dose of Warfarin) Patient operated first line without macroscopic residual for ovarian cancer or primary peritoneal or tubal stage IIIC or IV peritoneal pleural Minimum Required for surgery: hysterectomy, oophorectomy, pelvic lymphadenectomy and para-aortic omentectomy Patient requiring adjuvant chemotherapy Compulsory affiliation to a social security scheme. Obtaining informed consent in writing, signed and dated. Exclusion Criteria: Patient with cognitive and psychiatric disorders. Patient deprived of liberty by a court or administrative. Patient having directions against the achievement of chemotherapy Concomitant treatment with a drug test, participation in another therapeutic clinical trial within 30 days Pregnant women Nursing women Patient with recognized hypersensitivity to cisplatin or platinum-containing products Patient with hypersensitivity recognized paclitaxel or any of the excipients Patient must be vaccinated against yellow fever Patient before taking phenytoin for prophylactic purposes Patient with hearing impairment Patient with hepatic impairment Patient with renal impairment Sensory or motor -Neuropathies> grade 1 (CTCAE) Hépatite Or severe infection requiring parenteral antibiotics Serious non-healing wound or ulcer, or bone fracture Fistule Abdominal or gastrointestinal perforation, or intra-abdominal abscess in the 28 days preceding the intraperitoneal chemotherapy Clinical -Symptômes, gastrointestinal obstruction or signs and / or which require a hydration and / or parenteral nutrition Patientes Has had or currently with inflammatory bowel disease Active bleeding or medical condition that carries a high risk of bleeding (eg, known coagulation disorders, coagulopathy, or tumor with large vessels) Cerebrovascular accident (CVA) or transient ischemic attack, or subarachnoid hemorrhage in the last 6 months Disease clinically significant cardiovascular, including: uncontrolled hypertension, defined as systolic blood pressure> 150mmHg or diastolic> 90mmHg myocardial infarction or unstable angina within the last 6 months NYHA class II-IV congestive heart failure serious cardiac arrhythmia requiring treatment: -an asymptomatic atrial fibrillation with controlled ventricular rate supraventricular tachycardia or controlled with medication and is authorized asymptomatic peripheral vascular disease o ≥ Grade 2 (CTCAE) (brief [less than 24 hours] ischemia episodes managed non-surgically and without permanent deficit) Antecedents of Hemorrhage or stroke (stroke), transient ischemic attack, or subarachnoid in the last 6 months Major Surgery within 28 days prior to inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Pomel, MD, PhD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19955907
Citation
Harter P, Hilpert F, Mahner S, Kommoss S, Heitz F, Pfisterer J, du Bois A. Prognostic factors for complete debulking in first- and second-line ovarian cancer. Int J Gynecol Cancer. 2009 Dec;19 Suppl 2:S14-7. doi: 10.1111/IGC.0b013e3181bffb3f.
Results Reference
background
PubMed Identifier
8173187
Citation
de Forni M, Boneu A, Otal P, Martel P, Shubinski R, Bugat R, Lucot H. Anatomic changes in the abdominal cavity during intraperitoneal chemotherapy: prospective study using scintigraphic peritoneography. Bull Cancer. 1993 Apr;80(4):345-50.
Results Reference
background
PubMed Identifier
12885800
Citation
Varia MA, Stehman FB, Bundy BN, Benda JA, Clarke-Pearson DL, Alvarez RD, Long HJ; Gynecologic Oncology Group. Intraperitoneal radioactive phosphorus (32P) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003 Aug 1;21(15):2849-55. doi: 10.1200/JCO.2003.11.018.
Results Reference
background
PubMed Identifier
14645424
Citation
Young RC, Brady MF, Nieberg RK, Long HJ, Mayer AR, Lentz SS, Hurteau J, Alberts DS. Adjuvant treatment for early ovarian cancer: a randomized phase III trial of intraperitoneal 32P or intravenous cyclophosphamide and cisplatin--a gynecologic oncology group study. J Clin Oncol. 2003 Dec 1;21(23):4350-5. doi: 10.1200/JCO.2003.02.154.
Results Reference
background
PubMed Identifier
19849742
Citation
Dawson SJ, Hicks RJ, Johnston V, Allen D, Jobling T, Quinn M, Rischin D. Intraperitoneal distribution imaging in ovarian cancer patients. Intern Med J. 2011 Feb;41(2):167-71. doi: 10.1111/j.1445-5994.2009.02112.x.
Results Reference
background
PubMed Identifier
8960474
Citation
Alberts DS, Liu PY, Hannigan EV, O'Toole R, Williams SD, Young JA, Franklin EW, Clarke-Pearson DL, Malviya VK, DuBeshter B. Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med. 1996 Dec 26;335(26):1950-5. doi: 10.1056/NEJM199612263352603.
Results Reference
background
PubMed Identifier
16394300
Citation
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.
Results Reference
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Study of the Isotopic Distribution of Intraperitoneal Chemotherapy for Peritoneal Carcinomatosis of Ovarian Origin

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