IPHC in Patients With Platinum-sensitive Recurrent Ovarian Cancer

NCT01588964 | Completed Phase 2 DMC

• 1 other identifier: Prot.lf.P.177(A.200)/C.E./2005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Epithelial Cancer Recurrent

Keywords

HIPEC; ovarian cancer; recurrence

Outcome Measures

Primary Outcomes (1)

• Progression free survival,Overall survival, post operative complications(bowel obstruction,intestinal perforation, hemathologic toxicity (granulocytopenia,thrombocytopenia,anemia),neuropathy.

  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.

  6-32 months

Study Arms (1)

HIPEC

EXPERIMENTAL

Surgery plus HIPEC

Procedure: HIPEC

Interventions

HIPEC PROCEDURE

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.

Also known as: IPHC, Hypertermic intraperitoneal chemotherapy

HIPEC

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Related Publications (1)

• Fagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/j.ygyno.2013.12.028. Epub 2013 Dec 27.

  PMID: 24378877 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Recurrence

Interventions

Hyperthermic Intraperitoneal Chemotherapy

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: May 1, 2012
• Study Start: March 1, 2005
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 1, 2012

Record last verified: 2012-04