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Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163552
First Posted: July 15, 2010
Last Update Posted: June 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gary Schwartz, St. Luke's-Roosevelt Hospital Center
July 14, 2010
July 15, 2010
June 13, 2014
June 2010
May 2014   (Final data collection date for primary outcome measure)
  • Time to disease progression [ Time Frame: 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 [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01163552 on ClinicalTrials.gov Archive Site
  • Systemic drug absorption [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pleural Metastases
  • Breast Cancer
  • Colon Cancer
  • Ovarian Cancer
  • Uterine Cancer
  • Renal Cell Cancer
  • Thymic Cancer
Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.
Experimental: Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy
Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.
Intervention: Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01163552
SLR IRB#09-207
No
Not Provided
Not Provided
Gary Schwartz, St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Not Provided
Principal Investigator: Cliff P Connery, MD St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery
St. Luke's-Roosevelt Hospital Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP