Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Protocol: 
AAAQ9194
Phase: 
II

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

motherapy can improve survival in patients with metastatic adrenal cortical
carcinoma.

Are you Eligible? (Inclusion Criteria)

* Histologically proven ACC with the majority of disease confined to the
peritoneal
cavity and resectable; or disease that in the opinion of the investigators
can be managed medically or surgically and does not present an immediate
threat to the patient’s life.
* Disease evaluable by CT or PET imaging
* All disease should be deemed resectable based on imaging studies e.g.:
- Hepatic metastases (unilateral or bilateral ≤5 lesions, ≤15 cm
total diameter)
Note: Hepatic lesions must be amenable to complete resection
- Primary peritoneal metastases (small disease load ≤P2 disease)
without intestinal obstruction.
- Lung metastases (≤3 unilateral/bilateral, 9 cm total diameter)
Note: lung lesions must be amenable to complete resection.
Note: Patients with both pulmonary and hepatic metastases will be
enrolled at the discretion of the PI
Note: In situations where resection to Completeness of
Cytoreduction Score (CC) 0 or 1 is uncertain, patients may
undergo diagnostic laparoscopy prior to
enrollment to determine feasibility of resection. (Appendix D:
Completeness of Cytoreduction Score)
* Greater than or equal to 18 years of age
* Able to understand and sign the Informed Consent Document
* Clinical performance status of ECOG ≤2
* Life expectancy of greater than three months
* Patients of both genders must be willing to practice birth control
during and formfour months after receiving chemotherapy
* Hematology:
- Absolute neutrophil count greater than 1500/mm3 without the
support of filgrastim.
- Platelet count greater than 75,000/mm3
- Hemoglobin greater than 8.0 g/dl.
* Chemistry:
- Serum creatinine less than or equal to 1.5 mg/dl unless the
measured
creatinine clearance is greater than 60 mL/min/1.73 m2
- Serum AST and ALT within 5 times the upper limit of normal and
a total define the upper limit of grade 2 treatment related

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States