Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study

NCT00968799 | Terminated Results DMC

• 1 other identifier: SGOV01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount \[mg\] = dose \[mg/m²\] x body surface \[m²\]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Carcinoma

Keywords

Ovarian Neoplasms; Recurrence; Hyperthermia, Induced; Peritoneal Neoplasms; recurrent epithelial ovarian cancer; recurrent fallopian tube carcinoma

Outcome Measures

Primary Outcomes (1)

• Fitness for Systemic Chemotherapy

  Are patients fit to receive six courses of systemic carboplatin chemotherapy after completion of trial. If chemotherapy starts within 3 months after surgery and at least 4 courses could be administered, patient is considered fit. If chemotherapy is stopped early for reasons clearly unrelated to study treatment (e.g. platinum resistance), patient is also considered fit.

  3 months post operation

Secondary Outcomes (4)

• Nephrotoxicity

  6 weeks post operation

• Surgical Complications

  6 weeks post operation

• Overall Survival

  5 years

• Pharmacokinetics

  intraoperative and 1 week after surgery

Study Arms (1)

HIPEC treatment

EXPERIMENTAL

Cytoreduction Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) with cisplatin Perfusion of the peritoneum with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l). If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin). Perfusion is performed with the open or Coliseum technique for 90 min.

Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy; Procedure: Cytoreduction; Drug: Cisplatin

Interventions

Hyperthermic intraoperative intraperitoneal chemotherapy PROCEDURE

Perfusion of the peritoneum with 42°C warm 25 mg/l cisplatin solution.

Also known as: HIPEC

HIPEC treatment

Cytoreduction PROCEDURE

Surgical removal of tumor nodules including resection of organs infested with tumor

HIPEC treatment

Cisplatin DRUG

Cisplatin is applied as chemotherapy during surgery

Also known as: cis-diamminedichloroplatinum(II), cisplatinum, CDDP, Platinol

HIPEC treatment

Eligibility Criteria

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

You may qualify if:

• Patient with histologically confirmed and recurrent epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma requiring secondary debulking. Last chemotherapy of primary treatment was finished at least 6 months before.
• Patient must give written informed consent before registration
• WHO/ECOG performance status 0 - 1
• Age ≥18 years, ≤70 years
• Adequate hematological values: leukocytes ≥3x10\^9/l, thrombocytes ≥100x10\^9/l
• Adequate renal function. Obstructive hydronephrosis as a cause of "borderline" (30 - 45 ml/min) renal function should be investigated and treated prior to study entry.
• Patient compliance and geographic proximity allow proper staging and follow-up.
• FIGO III and IV

You may not qualify if:

• Primary diagnosis of epithelial ovarian cancer, or primary treatment completed less than 6 months ago.
• FIGO stage I + II
• Distant and current metastases
• WHO/ECOG performance status ≥2
• Inadequate hepatic function: bilirubin \>1.5x ULN (upper limit normal range) or ASAT/ALAT \>2.5x ULN or AP \>5x ULN
• Psychiatric disorder precluding understanding of information of trial related topics or giving informed consent
• Concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to trial entry
• Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes)
• Known hypersensitivity to cisplatin
• Any concomitant drugs contraindicated for use with the trial drugs according to the Swissmedic-approved product information
• Dehydration
• Impaired hearing or symptomatic peripheral neuropathy: ≥grade II NCI-CTCAEv3
• Regular use of anti-epileptics

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

Study Sites (1)

Department of Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms; Recurrence; Hyperthermia; Peritoneal Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Cytoreduction Surgical Procedures; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Surgical Procedures, Operative; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Sascha Müller, MD
• Organization: Cantonal Hospital St.Gallen

ulrich.beutner@kssg.ch

+41 71 494 1317

Study Officials

• Markus Lüdin, MD

  Cantonal Hospital St. Gallen, Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oberarzt

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: August 31, 2009
• Study Start: February 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 8, 2023
• Results First Posted: May 10, 2013

Record last verified: 2023-08

Locations

CH (1)