Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel in Advanced Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— hipecova  

Official title:

Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02681432
• Other study ID #: HGCRCIRU001
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Hospital General de Ciudad Real
• Contact: Pedro Villarejo Campos, MD,PhD
• Phone: 926278000
• Email: villarejocampos[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.

Description:

Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of the patients include in the trial, and it will be assign at randomization:

• HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

• No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women with histologically confirmed epithelial ovarian cancer (stage II / III / IV disease of FIGO) or tumor recurrences (the women of childbearing age need to have a negative pregnancy test)

• Complete cytoreduction: Index CC0/CC1 cytoreduction (residual tumor size after surgery, no visible (CC0) or less than 0.25 cm (CC1))

• No extra-abdominal tumor disease

• Absence of heart failure. Adequate renal and hepatic functions

• Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status = 70%

Exclusion Criteria:

• Patients with unresectable tumor or incomplete cytoreduction.

• Contraindications for treatment with paclitaxel: patients with severe hypersensitivity to paclitaxel or any of the excipients,pregnancy or lactation and patients with baseline neutrophil count <1.500/mm3 (<1.000/mm3 for patients with Kaposi sarcoma). Paclitaxel is also contraindicated in patients who have concurrent and severe infections.

• Extra-abdominal metastases or unresectable liver metastases

• Presence of other malignant tumor disease.

• Multisegmental complete bowel obstruction.

• Patients with severe medical problems that will preclude compliance with the study or with an unacceptable risk

• Patients who refuse treatment or consent to participate in study

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Fever
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• HIPEC
Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.

Procedure:
• No HIPEC
Cytoreductive surgery without HIPEC

Locations

Country	Name	City	State
Spain	Hospital General Ciudad Real	Ciudad Real

Sponsors (3)

Lead Sponsor	Collaborator
PEDRO VILLAREJO CAMPOS	Hospital General de Ciudad Real, University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

Benedetti Panici P, Palaia I, Graziano M, Bellati F, Manci N, Angioli R. Intraperitoneal paclitaxel as consolidation treatment in ovarian cancer patients: a case control study. Oncology. 2010;78(1):20-5. doi: 10.1159/000287968. Epub 2010 Feb 24. — View Citation

Bijelic L, Jonson A, Sugarbaker PH. Systematic review of cytoreductive surgery and heated intraoperative intraperitoneal chemotherapy for treatment of peritoneal carcinomatosis in primary and recurrent ovarian cancer. Ann Oncol. 2007 Dec;18(12):1943-50. Epub 2007 May 11. — View Citation

Chua TC, Robertson G, Liauw W, Farrell R, Yan TD, Morris DL. Intraoperative hyperthermic intraperitoneal chemotherapy after cytoreductive surgery in ovarian cancer peritoneal carcinomatosis: systematic review of current results. J Cancer Res Clin Oncol. 2009 Dec;135(12):1637-45. doi: 10.1007/s00432-009-0667-4. Epub 2009 Aug 23. Review. — View Citation

de Bree E, Rosing H, Filis D, Romanos J, Melisssourgaki M, Daskalakis M, Pilatou M, Sanidas E, Taflampas P, Kalbakis K, Beijnen JH, Tsiftsis DD. Cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy with paclitaxel: a clinical and pharmacokinetic study. Ann Surg Oncol. 2008 Apr;15(4):1183-92. doi: 10.1245/s10434-007-9792-y. Epub 2008 Feb 1. — View Citation

Jaaback K, Johnson N, Lawrie TA. Intraperitoneal chemotherapy for the initial management of primary epithelial ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 12;(1):CD005340. doi: 10.1002/14651858.CD005340.pub4. Review. — View Citation

Kim JH, Lee JM, Ryu KS, Lee YS, Park YG, Hur SY, Lee KH, Lee SH, Kim SJ. Consolidation hyperthermic intraperitoneal chemotherapy using paclitaxel in patients with epithelial ovarian cancer. J Surg Oncol. 2010 Feb 1;101(2):149-55. doi: 10.1002/jso.21448. — View Citation

Muñoz-Casares FC, Rufián S, Rubio MJ, Díaz CJ, Díaz R, Casado A, Arjona A, Muñoz-Villanueva MC, Muntané J. The role of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in the treatment of peritoneal carcinomatosis in recurrent ovarian cancer. Clin Transl Oncol. 2009 Nov;11(11):753-9. — View Citation

Seretis C, Youssef H. Quality of life after cytoreductive surgery and intraoperative hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies: a systematic review. Eur J Surg Oncol. 2014 Dec;40(12):1605-13. doi: 10.1016/j.ejso.2014.08.477. Epub 2014 Sep 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative complications	Compare adverse events between study arms	adverse events within 30 days postoperatively (according to NCI criteria, Common Terminology Criteria for AE (CTCAE))
Primary	Overall survival	From the date of surgery to the date of death or to the end of study (follow up every 6 months till 3 years)	every 6 months till 36 months
Secondary	Progression free survival	From the date of surgery to the date of recurrence or to the end of study (follow up every 6 months till 18 months)	follow up every 6 months till 18 months