Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Epithelial Ovarian Cancer Fallopian Tube Carcinoma |
Procedure: Hyperthermic intraoperative intraperitoneal chemotherapy Procedure: Cytoreduction Drug: Cisplatin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study |
- Fitness for Systemic Chemotherapy [ Time Frame: 3 months post operation ] [ Designated as safety issue: Yes ]
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.
- Nephrotoxicity [ Time Frame: 6 weeks post operation ] [ Designated as safety issue: Yes ]glomerular filtration rate (GFR)
- Surgical Complications [ Time Frame: 6 weeks post operation ] [ Designated as safety issue: Yes ]any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3)
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Pharmacokinetics [ Time Frame: intraoperative and 1 week after surgery ] [ Designated as safety issue: No ]data not analysed due to poor accrual
| Enrollment: | 6 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HIPEC treatment
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
Perfusion of the peritoneum with 42°C warm 25 mg/l cisplatin solution.
Other Name: HIPEC
Procedure: Cytoreduction
Surgical removal of tumor nodules including resection of organs infested with tumor Cisplatin is applied as chemotherapy during surgery
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Switzerland | |
| Department of Surgery, Cantonal Hospital St. Gallen | |
| St. Gallen, Switzerland, 9007 | |
| Principal Investigator: | Markus Lüdin, MD | Cantonal Hospital St. Gallen, Department of Surgery |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sascha Müller, Oberarzt, Cantonal Hospital of St. Gallen |
| ClinicalTrials.gov Identifier: | NCT00968799 History of Changes |
| Other Study ID Numbers: | SGOV01 |
| Study First Received: | February 12, 2008 |
| Results First Received: | March 26, 2013 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Switzerland: Ethikkommission Switzerland: Swissmedic |
Keywords provided by Cantonal Hospital of St. Gallen:
|
Ovarian Neoplasms Recurrence Hyperthermia, Induced |
Peritoneal Neoplasms recurrent epithelial ovarian cancer recurrent fallopian tube carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Fever Ovarian Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Body Temperature Changes Signs and Symptoms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013