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Completed

NCT Number: NCT01163552

Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

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.

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Key information

Conditions

Pleural Metastases Adenocarcinoma Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Renal Cell Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lymphatic Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Renal Cell Cancer Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Thymic Cancer Thymus Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cancer Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Luke's-Roosevelt Hospital Center

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

Procedure

Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Official study title

Surgical Cytoreduction Followed by Intraoperative Intrathoracic Hyperthermic Chemotherapy Perfusion for the Management of Disseminated Pleural Malignancies

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2010
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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