search
Back to results

Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
pemetrexed disodium
adjuvant therapy
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring epithelial mesothelioma, sarcomatous mesothelioma, localized malignant mesothelioma, recurrent malignant mesothelioma

Eligibility Criteria

undefined - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant pleural mesothelioma All subtypes allowed T1-3, N0-1, M0 disease No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus) No wide-spread chest wall invasion except focal chest wall lesions No clinical or radiological evidence of shrinking hemithorax No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis PATIENT CHARACTERISTICS: Age Under 70 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic WBC > 3,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin ≥ 11 g/dL Hepatic AST and ALT < 1.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN Alkaline phosphatase < 1.5 times ULN Renal Creatinine clearance ≥ 60 mL/min Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40% Pulmonary See Disease Characteristics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Deemed to be fit enough to undergo study treatment No preexisting sensory neurotoxicity > grade 1 No uncontrolled infection No prior or concurrent melanoma, breast cancer, or hypernephroma No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy Chemotherapy No prior chemotherapy for mesothelioma Endocrine therapy No concurrent hormonal cancer therapy Radiotherapy No prior radiotherapy to the lower neck, thorax, or upper abdomen Surgery See Disease Characteristics Other No other concurrent anticancer therapy No other concurrent experimental medications No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and 2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days after for drugs with a long half-life [e.g., naproxen, piroxicam, diflunisal, or nabumetone])

Sites / Locations

  • Universitair Ziekenhuis Antwerpen
  • Istituto Nazionale per la Ricerca sul Cancro
  • Azienda Ospedaliera Di Parma
  • Universita Degli Studi di Udine
  • Sint Antonius Ziekenhuis
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Edinburgh Cancer Centre at Western General Hospital

Outcomes

Primary Outcome Measures

Feasibility in terms of 90-day progression-free survival

Secondary Outcome Measures

Toxicity
Progression-free survival
Overall survival

Full Information

First Posted
September 26, 2005
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00227630
Brief Title
Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
Official Title
A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin followed by surgery and radiation therapy works in treating patients with malignant pleural mesothelioma.
Detailed Description
OBJECTIVES: Primary Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative 3D-conformal radiotherapy, in terms of 90-day progression-free survival, in patients with malignant pleural mesothelioma. Secondary Determine the toxicity of this regimen in these patients. Determine progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a non-randomized, multicenter study. Neoadjuvant chemotherapy: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated 3 weeks after completion of neoadjuvant chemotherapy. Patients without disease progression proceed to surgery. Extrapleural pneumonectomy: Within 21-56 days after completion of neoadjuvant chemotherapy, patients undergo extrapleural pneumonectomy. Patients are evaluated 30 days after surgery. Patients without disease progression undergo high-dose 3D-conformal radiotherapy. High-dose 3D-conformal radiotherapy: Beginning 30-84 days after surgery, patients undergo high-dose 3D-conformal radiotherapy daily for 30 days. After completion of study treatment, patients are followed on days 42 and 90, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
epithelial mesothelioma, sarcomatous mesothelioma, localized malignant mesothelioma, recurrent malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Feasibility in terms of 90-day progression-free survival
Secondary Outcome Measure Information:
Title
Toxicity
Title
Progression-free survival
Title
Overall survival

10. Eligibility

Sex
All
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant pleural mesothelioma All subtypes allowed T1-3, N0-1, M0 disease No N2 or N3 involvement confirmed by mediastinoscopy within 21 days before study entry No clinical invasion of mediastinal structures (e.g., heart, aorta, spine, esophagus) No wide-spread chest wall invasion except focal chest wall lesions No clinical or radiological evidence of shrinking hemithorax No clinically significant third-space fluid (e.g., pleural effusions or ascites) that cannot be managed with thoracentesis or pleurodesis PATIENT CHARACTERISTICS: Age Under 70 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic WBC > 3,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin ≥ 11 g/dL Hepatic AST and ALT < 1.5 times upper limit of normal (ULN) Bilirubin < 1.5 times ULN Alkaline phosphatase < 1.5 times ULN Renal Creatinine clearance ≥ 60 mL/min Acceptable (predicted) post-radiotherapy renal function by semiquantitative isotope renography, with a relative contribution of the contralateral kidney of ≥ 40% Pulmonary See Disease Characteristics Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Deemed to be fit enough to undergo study treatment No preexisting sensory neurotoxicity > grade 1 No uncontrolled infection No prior or concurrent melanoma, breast cancer, or hypernephroma No other malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent routine use of colony-stimulating factors during neoadjuvant chemotherapy Concurrent secondary prophylactic use allowed during neoadjuvant chemotherapy No concurrent secondary prophylactic use of colony-stimulating factors during post-operative radiotherapy Chemotherapy No prior chemotherapy for mesothelioma Endocrine therapy No concurrent hormonal cancer therapy Radiotherapy No prior radiotherapy to the lower neck, thorax, or upper abdomen Surgery See Disease Characteristics Other No other concurrent anticancer therapy No other concurrent experimental medications No nonsteroidal anti-inflammatory drugs or salicylates for 2 days before, during, and 2 days after administration of neoadjuvant chemotherapy (5 days before and 2 days after for drugs with a long half-life [e.g., naproxen, piroxicam, diflunisal, or nabumetone])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Van Schil, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Universita Degli Studi di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Daniel Den Hoed Cancer Center at Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3008 AE
Country
Netherlands
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21684151
Citation
O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16.
Results Reference
result
PubMed Identifier
20525721
Citation
Van Schil PE, Baas P, Gaafar R, Maat AP, Van de Pol M, Hasan B, Klomp HM, Abdelrahman AM, Welch J, van Meerbeeck JP; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group. Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial. Eur Respir J. 2010 Dec;36(6):1362-9. doi: 10.1183/09031936.00039510. Epub 2010 Jun 4.
Results Reference
result

Learn more about this trial

Pemetrexed Disodium and Cisplatin Followed By Surgery and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

We'll reach out to this number within 24 hrs