Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Study Overview
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Brief Summary
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Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.

Official Title
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Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies

Conditions
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Pleural Metastases, Breast Cancer, Colon Cancer, Ovarian Cancer, Uterine Cancer, Renal Cell Cancer, Thymic Cancer

Intervention / Treatment
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* Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 18-75 years Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer) Adequate liver and renal function defined as a bilirubin of < 2.0 mg/dl, albumin > 3.0g/dl, and a creatinine of < 1.5 mg/dl, respectively. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3. A Karnofsky Performance Status score of ≥60 Exclusion Criteria: Patients without satisfactory oncological control of their primary cancer. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease. Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study. Significant active medical disease including, but not limited to: Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias. Active infections Uncontrolled diabetes mellitus Chronic renal insufficiency HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded. Pregnant or lactating women. Allergy to intravenous contrast

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy<br>Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion. | Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy<br>* Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression | Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the time to disease progression of this experimental treatment modality. | 1 year | 
| Survival | Most cancers that have spread to the chest cavity have limited survival. Response to systemic chemotherapy and radiation therapy is short-lived. This end point will determine the overall survival period following treatment with this experimental modality. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic drug absorption | By perfusing the chest cavity with chemotherapy, higher doses can be safely administered as less drug is absorbed systemically and therefore toxicity should be lower. This end point will assess drug toxicity due to intrathoracic perfusion. | 1 month | 
| Complications | Patients will undergo surgical debulking prior to intrathoracic chemotherapy perfusion. Complications from the surgery as well as inhibited wound healing from chemotherapy will be monitored as a secondary end point. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pleural metastases