IPHC in Patients With Platinum-sensitive Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01588964
First received: April 24, 2012
Last updated: April 28, 2012
Last verified: April 2012
  Purpose

In patient with a platinum sensitive ovarian cancer recurrence is demonstrated that the re-challenge with a compound of platinum-based, or a treatment with carboplatin in combination with paclitaxel , determines a rate of clinical response similar to the primary treatment, which is all the more important as the longer the time to progression from the primary therapy.In the clinical setting there are many studies that have shown activity of oxaliplatin and docetaxel in patients with advanced ovarian cancer. Two recent studies have shown clinical efficacy of the combination carboplatin / docetaxel in the first line oxaliplatin / paclitaxel to recurrence of disease, confirming the data already obtained from studies of activity in a single agent.In surgery it has been demonstrated in a meta-analysis including approximately 7000 patients in advanced stages of disease, that the extent of cytoreduction is the most powerful determinant of survival.The role of secondary surgical cytoreduction in case of recurrent disease has yet to be determined because of the lack of prospective randomized clinical studies that may highlight the superiority of such aggressive treatment.The combination of aggressive cytoreductive surgery and hyperthermic intraperitoneal intraoperative chemotherapy (CHIP) used in recent clinical studies showed a prolonged time to progression and disease-free survival in patients with ovarian cancer. However, these studies were conducted on groups of patients with very different among themselves and with other drugs, it is difficult to draw definitive conclusions.Given the activities of oxaliplatin and docetaxel and their non-cross-resistance we designed a Phase 2 clinical trial on treatment of patients with recurrent ovarian cancer, platinum-sensitive, treated with surgical cytoreduction with hyperthermic oxaliplatin-based intraoperative intraperitoneal chemotherapy and following consolidation treatment with oxaliplatin and docetaxel systemically every 21 days.


Condition Intervention Phase
Ovarian Epithelial Cancer Recurrent
Procedure: HIPEC
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgery and Intraperitoneal Hyperthermic Chemotherapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer .

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Progression free survival,Overall survival, post operative complications(bowel obstruction,intestinal perforation, hemathologic toxicity (granulocytopenia,thrombocytopenia,anemia),neuropathy. [ Time Frame: 6-32 months ] [ Designated as safety issue: Yes ]
    Efficacy and tolerability of the treatment with intraoperative intraperitoneal hyperthermic chemotherapy with oxaliplatin after optimal debulking surgery in patients with platinum-sensitive recurrent ovarian cancer followed by systemic chemotherapy with docetaxel 75mg / m g1 and oxaliplatin 100 mg / m² every 21 days x g1 for six consecutive cycles.


Enrollment: 30
Study Start Date: March 2005
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIPEC
Surgery plus HIPEC
Procedure: HIPEC
surgery plus HIPEC with the closed technique(perfusion of the abdominal cavity with a solution containing oxaliplatin 460 mg/m2 in 2L/m2 heated saline at 42°C).The global temperature will be measured by thermometer inserted into the esophagus and rectum. A Swan-Ganz catheter will be kept in place during the HIPEC for monitoring cardiovascular function.
Other Names:
  • IPHC
  • Hypertermic intraperitoneal chemotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 and under 70 years
  • Patients affected by a first recurrence of ovarian cancer with measurable lesions or not, but evaluable (upwards of Ca125 for 2 consecutive assessments).
  • ECOG-performance status ≤ 2
  • Ovarian cancer limited to the abdominal cavity with or without extraperitoneal spread considered resectable at intraoperative evaluation
  • Evidence of tumor recurrence diagnosed after 6 months from primary treatment
  • Previous-based chemotherapy of carboplatin and taxanes
  • Positive Peritoneal Washing in the presence of other abdominal disease surgically resectable
  • Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count > 1500/mm3, platelets > 150,000/μl, creatinine clearance > 60 mL/min according to Cockroft formula)
  • Patient-compliant and psychologically able to follow the trial procedures

Exclusion Criteria:

  • Non-epithelial ovarian cancer or borderline ovarian tumor
  • Pregnancy or breastfeeding
  • Patients affected by major depressive disorder even in treatment or minor mood disorders
  • Patients with severe impairment of respiratory, hepatic or renal function
  • Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
  • Patients with active infection or other neoplastic disease in progress
  • Patients with bowel obstruction
  • Inadequate bone marrow, liver, kidney function
  • No clear-peritoneal disease at surgical exploration
  • Patients with ascites > 500 ml (the TAC)
  • Patients on maintenance therapy with Antiangiogenic drugs
  • Patients with secondary or tertiary recurrence, or already submitted to HIPEC
  • Patients who have already made the second or third line chemotherapy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588964

Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Anna Fagotti, MD, PhD Catholic University of Sacred Heart
Principal Investigator: Gabriella Ferrandina, MD Catholic University of Sacred Heart
Principal Investigator: Ida Paris, MD Catholic University of Sacred Heart
  More Information

No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Giovanni Scambia, Clinical Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01588964     History of Changes
Other Study ID Numbers: Prot.lf.P.177(A.200)/C.E./2005
Study First Received: April 24, 2012
Last Updated: April 28, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Catholic University of the Sacred Heart:
HIPEC
ovarian cancer
recurrence

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014