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Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

Primary Purpose

Pleural Metastases, Breast Cancer, Colon Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Metastases focused on measuring pleural metastases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy

Arm Description

Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.

Outcomes

Primary Outcome Measures

Time to disease progression
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
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

Systemic drug absorption
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
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.

Full Information

First Posted
July 14, 2010
Last Updated
June 12, 2014
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01163552
Brief Title
Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity
Official Title
Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Metastases, Breast Cancer, Colon Cancer, Ovarian Cancer, Uterine Cancer, Renal Cell Cancer, Thymic Cancer
Keywords
pleural metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy
Arm Type
Experimental
Arm Description
Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.
Intervention Type
Procedure
Intervention Name(s)
Surgical debulking and Intrathoracic Hyperthermic Chemotherapy
Intervention Description
Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.
Primary Outcome Measure Information:
Title
Time to disease progression
Description
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.
Time Frame
1 year
Title
Survival
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Systemic drug absorption
Description
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.
Time Frame
1 month
Title
Complications
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cliff P Connery, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7818311
Citation
Matsuzaki Y, Shibata K, Yoshioka M, Inoue M, Sekiya R, Onitsuka T, Iwamoto I, Koga Y. Intrapleural perfusion hyperthermo-chemotherapy for malignant pleural dissemination and effusion. Ann Thorac Surg. 1995 Jan;59(1):127-31. doi: 10.1016/0003-4975(94)00614-D.
Results Reference
background
PubMed Identifier
10096972
Citation
Ratto GB, Civalleri D, Esposito M, Spessa E, Alloisio A, De Cian F, Vannozzi MO. Pleural space perfusion with cisplatin in the multimodality treatment of malignant mesothelioma: a feasibility and pharmacokinetic study. J Thorac Cardiovasc Surg. 1999 Apr;117(4):759-65. doi: 10.1016/S0022-5223(99)70297-7.
Results Reference
background
PubMed Identifier
11596038
Citation
Yellin A, Simansky DA, Paley M, Refaely Y. Hyperthermic pleural perfusion with cisplatin: early clinical experience. Cancer. 2001 Oct 15;92(8):2197-203. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-f.
Results Reference
background
PubMed Identifier
10216479
Citation
Iyoda A, Yusa T, Hiroshima K, Fujisawa T. Surgical resection combined with intrathoracic hyperthermic perfusion for thymic carcinoma with an intrathoracic disseminated lesion: a case report. Anticancer Res. 1999 Jan-Feb;19(1B):699-702.
Results Reference
background
PubMed Identifier
11515868
Citation
Refaely Y, Simansky DA, Paley M, Gottfried M, Yellin A. Resection and perfusion thermochemotherapy: a new approach for the treatment of thymic malignancies with pleural spread. Ann Thorac Surg. 2001 Aug;72(2):366-70. doi: 10.1016/s0003-4975(01)02786-2.
Results Reference
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Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

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