Articles and Resources

Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, December 2010

First Received: July 11, 2008

Last Updated: December 6, 2010

Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: Eli Lilly and Company
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00715611

Purpose

For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and toxicity of standard chemotherapy +/-pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma.

Condition Intervention Phase
Mesothelioma Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy Phase II
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Toxicity Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma.
Resource links provided by NLM:

MedlinePlus related topics:

Cancer

Mesothelioma

Drug Information available for:

Cisplatin

Carboplatin

Pemetrexed

Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

  • To determine the safety (specifically in regards to pneumonitis) of chemotherapy +/- pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

  • To determine the response rate, progression free and overall survival rates of patients with malignant pleuralmesothelioma treated with chemotherapy, with or without P/D, followed by IMRT to the pleura. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the relationship between response to treatment and the levels of soluble mesothelin-related peptide (SMRP) and osteopontin. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the pattern of progression: local recurrence versus metastatic disease. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Estimated Enrollment: 28
Study Start Date: July 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental
This is a single institution phase II toxicity study of chemotherapy +/- Pleurectomy/Decortication (P/D) followed by Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Patients will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2 ) or carboplatin (AUC=5) every 3 weeks. After completion of the chemotherapy, patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will have this performed and four to six weeks later they will be treated with IMRT, 50.4 Gy in 28 fractions. If patients have unresectable disease, they will be treated with IMRT, 50.4 Gy in 28 fractions after completion of the chemotherapy.
Intervention: Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Other: Pemetrexed + Cisplatin or Carboplatin AUC=5 Pleurectomy/decortication (if feasible) Intensity Modulated Radiation Therapy
Patients who are potential candidates for pleurectomy/decortication (P/D) at the time of enrollment will receive up to four cycles of pemetrexed (500mg/m2) and cisplatin (75mg/m2) or carboplatin (AUC=5) every 3 weeks. Four to six weeks later chemotherapy, P/D will be attempted and four to six later they will be treated with IMRT, 50.4 Gy in 28 fractions.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • Patients must have a pathologically confirmed diagnosis of malignant pleural mesothelioma.
  • No evidence of metastatic disease.
  • No prior chemotherapy for mesothelioma.
  • No prior radiation therapy except for localized prostate or pelvic radiation
  • Patient age ≥ or = to 18 years on day of signing informed consent.
  • Karnofsky performance status ≥ or = to 70%
  • Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  • Patient must have the ability to interrupt NSAIDS 2 days before (5 days for longacting NSAIDs), the day of, and 2 days following administration of pemetrexed.
  • Pulmonary Function Tests:
  • FEV1 ≥ 30% of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative V/Q scan:
  • Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report.
  • DLCO > 35% predicted
  • Patient must have adequate organ function as indicated by the following laboratory values:
  • Hematological:
  • Absolute neutrophil count ≥ or = to 1,500 /mcL
  • Platelets ≥ or = to 100,000 / mcL
  • Renal Calculated creatinine clearance (CrCl) ≥ or = to 55 mL/min (Creatinine clearance must be calculated using Cockcroft & Gault method)
  • Hepatic
  • Serum total bilirubin ≤ or = to 1.5 X upper limit of normal (ULN) AST (SGOT) or ALT (SGPT) ≤ or = to 3.0 X ULN

Exclusion Criteria:

  • Pregnant or lactating women, or men or women not using effective contraception.
  • Patients with resectable disease for whom extrapleural pneumonectomy is necessary.
  • Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments.
  • Patients with a concurrent active malignancy.
  • Patients with serious unstable medical illness.
  • Presence of third space fluid that cannot be controlled by drainage. For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy consideration should be given to draining the effusion prior to dosing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715611

Contacts
Contact: Lee Krug, MD 212-639-8420
Contact: Andreas Rimner, MD 212-639-6025

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Lee Krug, MD     212-639-8420
Contact: Andreas Rimner, MD     212-639-6025
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Lee Krug, MD     212-639-8420
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lee Krug, MD     212-639-8420
Contact: Andreas Rimner, MD     212-639-6025
Principal Investigator: Lee Krug, MD
Memorial Sloan-Kettering at Mercy Medical Center Recruiting
Rockville Centre, New York, United States
Contact: Lee Krug, MD     212-639-8420
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Lee Krug, MD     212-639-8420
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Eli Lilly and Company
Investigators
Principal Investigator: Lee Krug, MD Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Lee M. Krug, M. D. )
ClinicalTrials.gov Identifier: NCT00715611

History of Changes

Other Study ID Numbers: 08-053
Study First Received: July 11, 2008
Last Updated: December 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

pemetrexed

cisplatin

IMRT

PLEURA

Malignant

08-053

Additional relevant MeSH terms:

Mesothelioma

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms

Neoplasms, Mesothelial

Pemetrexed

Cisplatin

Carboplatin

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

Radiation-Sensitizing Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action

Folic Acid Antagonists

Antimetabolites, Antineoplastic

Antimetabolites

ClinicalTrials.gov processed this record on February 28, 2011

Source: http://www.clinicaltrials.gov