Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Phase 2

Completed

• Conditions: Uterine Cancer; Renal Cell Cancer; Thymic Cancer; Pleural Metastases; Breast Cancer; Colon Cancer; Ovarian Cancer
• Interventions: Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

• Registration Number: NCT01163552
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy	Surgical debulking and Intrathoracic Hyperthermic Chemotherapy	Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.

Primary Outcome Measures

Name	Time	Method
Time to disease progression	1 year	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.
Survival	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Systemic drug absorption	1 month	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.
Complications	1 month	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.

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States