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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):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pleural Metastases Breast Cancer Colon Cancer Ovarian Cancer Uterine Cancer Renal Cell Cancer Thymic Cancer Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies
Study Start Date : June 2010
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy
Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163552


Locations
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Cliff P Connery, MD St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery
More Information

Publications:
Responsible Party: Gary Schwartz, MD, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01163552     History of Changes
Other Study ID Numbers: SLR IRB#09-207
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014

Keywords provided by Gary Schwartz, St. Luke's-Roosevelt Hospital Center:
pleural metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Renal Cell
Uterine Neoplasms
Thymus Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Thoracic Neoplasms
Lymphatic Diseases