Cytoreductive Surgery and Heated Cisplatin in Treating Patients with Adrenocortical Cancer
This phase II trial studies how well cytoreductive surgery and heated cisplatin work in treating patients with adrenocortical cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving heated cisplatin directly into the abdomen after cytoreductive surgery may prevent or increase the length of time that it takes for the tumors to grow back.
Inclusion Criteria
- Histologically proven adrenocortical carcinoma (ACC) with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation; 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 computed tomography (CT) or positron emission tomography (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 principal investigator (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
- Greater than or equal to 18 years of age
- Able to understand and sign the informed consent document
- Clinical performance status of Eastern Cooperative Oncology Group (ECOG) =< 2
- Life expectancy of greater than three months
- Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy
- Absolute neutrophil count greater than 1500/mm^3 without the support of filgrastim
- Platelet count greater than 75,000/mm^3
- Hemoglobin greater than 8.0 g/dl
- Serum creatinine less than or equal to 1.5 mg/dl unless the measured creatinine clearance is greater than 60 mL/min/1.73 m^2
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal and a total serum bilirubin of less than 3 times the upper limit of normal, both of which define the upper limit of grade 2 treatment related toxicities
- Prothrombin time (PT) within 2 seconds of the upper limit of normal (institutional normal ratio [INR] =< 1.8)
- Recovered from any toxicity to grade 2 or less from all prior chemotherapy, immunotherapy or radiotherapy and be at least 30 days past the date of their last treatment with the exception of mitotane which may be continued
- Able to understand their disease and the exploratory nature of combining surgery and HIPEC for this histology
Exclusion Criteria
- Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure
- Hydronephrosis or biliary obstruction as these are usually signs of unresectability
- History of congestive heart failure and/or an left ventricular ejection fraction (LVEF) < 40%; echocardiography performed only as indicated based on clinical signs or symptoms
- Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease with pulmonary function tests (PFT’s) indicating an forced expiratory volume in 1 second (FEV1) less than 50% or a carbon monoxide diffusing capability test (DLCO) less than 40% predicted for age; PFTs performed only as indicated based on clinical signs or symptoms
- Grade 2 or greater neuropathy
- Women of child bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant
- Brain metastases or a history of brain metastases
- Childs B or C cirrhosis
- Evidence of severe portal hypertension by history, endoscopy, or radiologic studies * Note: Any diagnosis of portal hypertension or clinical stigmata of such including but not limited to gastric or esophageal varices, umbilical vein varices or telangiectasias
- Weight < 30 kg
- Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction within the last 6 months, life threatening cardiac arrhythmias, obstructive or restrictive pulmonary disease
Additional locations may be listed on ClinicalTrials.gov for NCT03127774.
Locations matching your search criteria
United States
New York
New York
PRIMARY OBJECTIVE:
I. To determine intraperitoneal progression free survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer.
SECONDARY OBJECTIVES:
I. Determine morbidity of this procedure in this patient population.
II. Determine the impact of surgery and heated intraperitoneal chemotherapy (HIPEC) on quality of life (QOL).
III. Determine the impact of surgery and HIPEC on hormone excess.
IV. Examine patterns of recurrence (local versus systemic).
V. Perform molecular analyses to try to discern if there are intrinsic differences between tumors that recur widely throughout the peritoneal surface and those that metastasize to other organs or are confined to a local recurrence.
VI. Determine overall survival after optimal debulking and heated intraperitoneal chemotherapy with cisplatin in patients with intraperitoneal spread of adrenocortical cancer.
OUTLINE:
Patients undergo cytoreductive surgery and receive cisplatin via heated intraperitoneal perfusion over 90 minutes. Patients may undergo echocardiography (ECHO), radionuclide bone scan, brain magnetic resonance imaging (MRI), and/or positron emission tomography/computed tomography (PET/CT) during screening and follow up as clinically indicated.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorKazuki Sugahara
- Primary IDAAAQ9194
- Secondary IDsNCI-2017-01520
- ClinicalTrials.gov IDNCT03127774