Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

St. Luke's-Roosevelt Hospital Center5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pleural Metastases Breast Cancer Colon Cancer Ovarian Cancer Uterine Cancer Renal Cell Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 18-75 years 2. Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis. 3. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer) 4. 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. 5. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3. 6. A Karnofsky Performance Status score of ≥60 Exclusion Criteria: 1. Patients without satisfactory oncological control of their primary cancer. 2. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease. 3. 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. 4. 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. 5. Pregnant or lactating women. 6. Allergy to intravenous contrast

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.