Epithelial Ovarian Cancer Clinical Trial
Official title:
Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study
NCT number | NCT00968799 |
Other study ID # | SGOV01 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2008 |
Est. completion date | December 2012 |
Verified date | August 2023 |
Source | Cantonal Hospital of St. Gallen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | December 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Surgery, Cantonal Hospital St. Gallen | St. Gallen |
Lead Sponsor | Collaborator |
---|---|
Cantonal Hospital of St. Gallen |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Nephrotoxicity | glomerular filtration rate (GFR) | 6 weeks post operation | |
Secondary | Surgical Complications | any serious surgical event (Dindo scale >= III (reoperation required) or CTCAE grade >=3) | 6 weeks post operation | |
Secondary | Overall Survival | 5 years | ||
Secondary | Pharmacokinetics | data not analysed due to poor accrual | intraoperative and 1 week after surgery |
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