Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

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Brief Title

Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression Free Survival

Secondary Outcome

 Morbidity Rate

Condition

Adrenocortical Carcinoma

Intervention

Cisplatin

Study Arms / Comparison Groups

 Surgery with HIPEC
Description:  Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

September 22, 2017

Completion Date

May 2023

Primary Completion Date

May 2022

Eligibility Criteria

        INCLUSION CRITERIA

          -  Histologically proven ACC with the majority of disease confined to the peritoneal
             cavity and resectable or amenable to radiofrequency ablation

          -  Disease evaluable by CT or Positron Emission Tomography (PET) imaging

          -  All disease should be deemed resectable based on imaging studies e.g.:

               -  Hepatic metastases (unilateral or bilateral less than or equal to 5 lesions, less
                  than or equal to 15 cm total diameter)

               -  Note: Hepatic lesions must be amenable to complete resection

               -  Primary peritoneal metastases (small disease load less than or equal to P2
                  disease) without massive ascites or intestinal obstruction

               -  Lung metastases (less than or equal to 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.

          -  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) less than or
             equal to 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

          -  Hematology:

               -  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.

          -  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 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 (INR less
                  than or equal to 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.

          -  History of congestive heart failure and/or an left ventricular ejection fraction
             (LVEF) less than 40%

        Note: Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g.,
        greater than 65yo, diabetes, history of hypertension, elevated LDL, first degree relative
        with coronary artery disease) will undergo full cardiac evaluation and will not be eligible
        if they demonstrate significant irreversible ischemia on stress thallium or an ejection
        fraction less than 40%.

        - Significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary
        restrictive disease with pulmonary function test (PFT) indicating an forced expiratory
        volume at one second (FEV1) less than 50% or a diffusing capacity of lung for carbon
        monoxide (DLCO) less than 40% predicted for age.

        Note: Patients who have shortness of breath with minimal exertion or who are at risk for
        pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will
        not be eligible if their FEV1 is less than 50% of expected.

          -  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 less than 30 kg

          -  Active systemic infections, coagulation disorders or other major medical illnesses of
             the cardiovascular, respiratory or immune system, myocardial infarction, cardiac
             arrhythmias, obstructive or restrictive pulmonary disease
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Michael Kluger, MD, 212-305-6514, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03127774

Organization ID

AAAQ9194


Responsible Party

Principal Investigator

Study Sponsor

Columbia University


Study Sponsor

Michael Kluger, MD, Principal Investigator, Columbia University


Verification Date

August 2019