Objectives: \- To determine intraperitoneal (IP) progression free survival after optimal debulking and heated intraperitoneal chemotherapy (HIPEC) with cisplatin in patients with IP spread of adrenocortical cancer. \- Determine morbidity of this procedure in this patient population. \- Determine the impact of surgery and HIPEC on quality of life (QOL) and hormone excess. \- Examine patterns of recurrence (local versus systemic). \- Determine overall survival after optimal debulking and HIPEC in patients with IP spread of adrenocortical cancer.
Adrenocortical carcinoma (ACC) is a rare tumor with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months. The treatment of choice for a localized primary or recurrent tumor is surgical resection of all visible tumor and involved organs. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used. This would be the standard of care alternative treatment. Cisplatin is one of the most effective chemotherapeutic agents for ACC. Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin have been conducted in other tumors that spread primarily to the peritoneal lining of the abdomen. Synergy has been demonstrated for cisplatin and hyperthermia. The purpose of this trial is to determine if an surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2 Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)
Route of administration: Intravenous Loading dose of 7.5 gm/m2 over 20 minutes followed by 2.13 gm/m2/hr for 12 hours Drug 2 given intravenously during hyperthermic intraperitoneal chemotherapy (HIPEC)
Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.
Columbia University Medical Center
New York, New York, United States
RECRUITINGProgression Free Survival
The length of time after optimal debulking and heated intraperitoneal chemotherapy that a patient lives before there is clinical evidence of recurrent adrenocortical cancer.
Time frame: Up to 5 years
Morbidity Rate
The frequency of post-operative complications.
Time frame: Up to 5 years
Quality of Life (QOL) Score
This measures the impact of surgery and HIPEC on quality of life.
Time frame: Up to 5 years
Overall Survival
The length of time people are alive after surgery and HIPEC for adrenocortical cancer.
Time frame: Up to 5 years
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