Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Completed · Phase 2

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

In brief

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.

Key facts

Study ID

NCT01163552

Run by

St. Luke's-Roosevelt Hospital Center

People needed

5

Starts

2010-06-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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