Breast Cancer Clinical Trial

Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT01163552

Recruitment Status:

Completed

Sponsor:

St. Luke's-Roosevelt Hospital Center

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There is 1 Location for this study

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St. Luke's-Roosevelt Hospital Center
New York New York, 10019, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT01163552

Recruitment Status:

Completed

Sponsor:


St. Luke's-Roosevelt Hospital Center

How clear is this clinincal trial information?

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