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Status:

COMPLETED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Malignant Mesothelioma

Eligibility:

All Genders

Up to 69 years

Phase:

PHASE2

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 dividin...

Detailed Description

OBJECTIVES: Primary * Determine the feasibility of neoadjuvant chemotherapy comprising pemetrexed disodium and cisplatin followed by extrapleural pneumonectomy and high-dose postoperative 3D-conform...

Eligibility Criteria

Inclusion

  • 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 \[e.g., naproxen, piroxicam, diflunisal, or nabumetone\])

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    59 Patients enrolled

    Trial Details

    Trial ID

    NCT00227630

    Start Date

    July 1 2005

    Last Update

    July 18 2012

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Universitair Ziekenhuis Antwerpen

    Edegem, Belgium, B-2650

    2

    Istituto Nazionale per la Ricerca sul Cancro

    Genoa, Italy, 16132

    3

    Azienda Ospedaliera Di Parma

    Parma, Italy, 43100

    4

    Universita Degli Studi di Udine

    Udine, Italy, 33100