Pleurectomy/Decortication With Intraoperative Intrathoracic/Intraperitoneal Heated Cisplatin With Sodium Thiosulfate

NCT00165503 | Terminated Phase 2 Results DMC

• 1 other identifier: 04-063
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The purposes of this study are: to determine the feasibility of administering adjuvant cisplatin plus ALIMTA to patients who undergo surgery with heated cisplatin during surgery; to determine the effects (good and bad) of this combined modality approach in patients with mesothelioma; to evaluate cisplatin effects by determining where it goes and how it is excreted in the body from the collection of tissues and cisplatin samples; to collect and analyze discarded samples of mesothelioma tumor during surgery to help determine the genetic make-up of the disease.

Conditions

Pleural Mesothelioma; Malignant Pleural Mesothelioma

Keywords

pleurectomy; decortication; cisplatin; ALIMTA

Outcome Measures

Primary Outcomes (1)

• Adjuvant Chemotherapy Completion Rate

  Feasibility in this study was based on the adjuvant chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of cisplatin and Alimta beginning 6-10 weeks after surgery with hyperthermic cisplatin.

  Given the 21-day cycle, 3 cycles of adjuvant chemotherapy approximates 9 weeks in addition to the time from registration and post-surgery which was up to 10 weeks.

Study Arms (1)

Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT

EXPERIMENTAL

Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.

Drug: Cisplatin; Drug: Sodium Thiosulfate; Drug: ALIMTA

Interventions

Cisplatin DRUG

Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT

Sodium Thiosulfate DRUG

Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT

ALIMTA DRUG

Also known as: pemetrexed

Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologic confirmation of malignant pleural mesothelioma
• Patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion or those with minimal disease
• Male on non-pregnant female
• years of age or older
• No evidence of spread outside the ipsilateral hemithorax by chest CT and chest MRI
• Ejection fraction \> 45%
• Pre-operative WBC \> 4K/uL
• Estimated life expectancy of at least 12 weeks
• Evidence of adequate renal and hepatic function
• Grossly normal contralateral pulmonary function with a chest radiograph and chest CT scan
• Karnofsky performance status of 70% or greater
• No evidence of disease progression by chest CT or chest MRI, obtained at 8 weeks following surgery

You may not qualify if:

• Extended disease outside the ipsilateral hemithorax as determined on pre-operative radiographs or intraoperative findings
• Positive extrapleural nodes as determined by mediastinoscopy
• Gross disease (estimated thickness \> 10mm at any intrathoracic location) present within the hemithorax after surgery
• Evidence of distant metastatic disease
• Severe non-malignant co-morbid disease, uncontrolled angina, myocardial infarction on the past 6 months, renal insufficiency, liver disease, pulmonary hypertension
• Pregnant or breast-feeding
• Serious concomitant systemic disorders
• Presence of active concomitant malignancy
• Psychiatric or addictive disorders, which would preclude informed consent
• Previous chemotherapy or radiation therapy for mesothelioma
• Chemotherapy or radiation therapy administered within 3 years for another malignancy

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Cisplatin; sodium thiosulfate; Pemetrexed

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Limitations and Caveats

This trial was terminated due to low accrual and feasibility.

Results Point of Contact

• Title: Dr. David Sugarbaker
• Organization: Brigham and Women's Hospital

dsugarbaker@partners.org

617-732-5004

Study Officials

• David J. Sugarbaker, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: April 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 9, 2016
• Results First Posted: September 9, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)