Clinical trial NCT01163552: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pleural Metastases
Breast Cancer
Colon Cancer
Ovarian Cancer
Uterine Cancer
Renal Cell Cancer
Thymic Cancer
Keywords: pleural metastases
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Time to disease progression
timeFrame: 1 year
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: Systemic drug absorption
timeFrame: 1 month
measure: Complications
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center, Division of Thoracic Surgery
name: Cliff P Connery, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.