Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity



Status:Completed
Conditions:Breast Cancer, Colorectal Cancer, Ovarian Cancer, Cervical Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:5/5/2014
Start Date:June 2010
End Date:June 2013
Contact:Cliff P Connery, MD
Email:cconnery@chpnet.org
Phone:2125237475

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

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.


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
We found this trial at
1
site
1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
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from
New York, NY
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