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

NCT02667925 | Withdrawn

• 1 other identifier: 2012-004103-12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; intraperitoneal chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 1. fixation of low intensity 2. fixation of high intensity

  During the 6 cycles of chemotherapy, that is during 18 weeks

Secondary Outcomes (4)

• Note adverse events assessed with CTCAE v4.0

  During the 6 cycles of chemotherapy, that is during 18 weeks

• Correlate pain intensity to fixation intensity in the peritoneal cavity

  During the 6 cycles of chemotherapy, that is during 18 weeks

• dosimetric study with peritoneal scintigraphy

  During the 6 cycles of chemotherapy, that is during 18 weeks

• Correlate site of relapse to localisation of labeled intraperitoneal solvent by nanocis in peritoneal cavity

  During 5 years after chemotherapy

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Drug: Intraperitoneal cisplatin with nanocis

Interventions

Intraperitoneal cisplatin with nanocis DRUG

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

Intervention arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Related Publications (7)

• 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.

  PMID: 19955907 BACKGROUND

• 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.

  PMID: 8173187 BACKGROUND

• 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.

  PMID: 12885800 BACKGROUND

• 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.

  PMID: 14645424 BACKGROUND

• 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.

  PMID: 19849742 BACKGROUND

• 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.

  PMID: 8960474 BACKGROUND

• 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.

  PMID: 16394300 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

nanocis

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Christophe Pomel, MD, PhD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 29, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)