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Alkylating agents

HIPEC for Adrenocortical Cancer

Phase 2
Recruiting
Led By Michael Kluger, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hematology: Absolute neutrophil count greater than 1500/mm^3 without the support of Filgrastim
Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
Must not have
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
Grade 2 or greater neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at the effectiveness of surgery and chemotherapy in treating patients with adrenocortical cancer that has spread to the abdomen.

Who is the study for?
This trial is for adults with Adrenocortical Carcinoma (ACC) where the majority of cancer is in the peritoneal cavity and can be surgically removed or treated with radiofrequency ablation. Participants must have a life expectancy over three months, practice birth control, and have adequate organ function. Excluded are those with severe heart, lung conditions, active infections, significant neuropathy, brain metastases or pregnant/breastfeeding women.
What is being tested?
The study tests if surgery followed by Heated Intraperitoneal Chemotherapy (HIPEC) using cisplatin improves survival without cancer spreading inside the abdomen. It also examines side effects, quality of life changes post-treatment and whether cancer comes back locally or spreads elsewhere.
What are the potential side effects?
Potential side effects include complications from major surgery and chemotherapy such as infection risk increase, bleeding issues due to low platelet counts, kidney damage indicated by elevated creatinine levels or reduced clearance rate; liver problems shown by high AST/ALT levels; blood clotting difficulties seen in abnormal prothrombin time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My white blood cell count is healthy without needing medication.
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I can perform daily activities with minimal assistance.
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My scans show that my cancer can be surgically removed.
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I am 18 years old or older.
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My disease can be seen on a CT or PET scan.
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My cancer is mainly in the belly area and can be surgically removed or treated with a special procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lung disease with very low lung function test results.
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I have moderate to severe nerve pain or damage.
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I do not have major illnesses like heart disease, severe infections, or blood clotting disorders.
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I weigh less than 30 kg.
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My liver disease is at a moderate to severe stage.
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I have a history of heart failure or my heart pumps less effectively.
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I have or had brain metastases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
Morbidity Rate
Overall Survival
Quality of Life (QOL) Score

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Dyspnoea
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Surgery with HIPECExperimental Treatment3 Interventions
Cytoreductive surgery followed by HIPEC with cisplatin and sodium thiosulfate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoreductive surgery
2013
Completed Phase 3
~180
Sodium thiosulfate
2009
Completed Phase 2
~50
Cisplatin
2013
Completed Phase 3
~3120

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,222 Total Patients Enrolled
Michael Kluger, MD4.930 ReviewsPrincipal Investigator - Columbia University
Columbia University
5Patient Review
Dr. Kluger was excellent. He was very informative and easy to talk to. I feel confident in his abilities and would recommend him to others.

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03127774 — Phase 2
Adrenocortical Cancer Research Study Groups: Surgery with HIPEC
Adrenocortical Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03127774 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03127774 — Phase 2
~4 spots leftby Dec 2025
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