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Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

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.
 
ClinicalTrials.gov Identifier: NCT01163552
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Gary Schwartz, St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date June 13, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01163552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
Official Title  ICMJE Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pleural Metastases
  • Breast Cancer
  • Colon Cancer
  • Ovarian Cancer
  • Uterine Cancer
  • Renal Cell Cancer
  • Thymic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
5
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
10
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163552
Other Study ID Numbers  ICMJE SLR IRB#09-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Schwartz, St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cliff P Connery, MD St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date June 2014

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