CClinicalTrials.gg
CompletedNCT00227630Updated Jul 18, 2012

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

A Phase 2 interventional study of cisplatin and pemetrexed disodium in Malignant Mesothelioma, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 8 sites in 4 countries. Open to participants aged Up to 69 Years. Per ClinicalTrials.gov, last updated 2012-07-18.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Non-randomized
Ages
Up to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Mesothelioma

Keywords

  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • localized malignant mesothelioma
  • recurrent malignant mesothelioma
03

In context

Mesothelioma

470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.

This study's enrollment of 59 is above the median of 40 across 371 interventional studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 69 Years
Sexes eligible
All
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])
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Enrollment
59 participants (actual)

Interventions

  • Drugcisplatin
  • Drugpemetrexed disodium
  • Procedureadjuvant therapy
  • Procedureconventional surgery
  • Procedureneoadjuvant therapy
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Feasibility in terms of 90-day progression-free survival

Secondary outcomes

  1. Toxicity

  2. Progression-free survival

  3. Overall survival

07

Study locations

8 sites
  • Universitair Ziekenhuis Antwerpen
    Edegem, B-2650, Belgium
  • Istituto Nazionale per la Ricerca sul Cancro
    Genoa, 16132, Italy
  • Azienda Ospedaliera Di Parma
    Parma, 43100, Italy
  • Universita Degli Studi di Udine
    Udine, 33100, Italy
  • Sint Antonius Ziekenhuis
    Nieuwegein, 3435 CM, Netherlands
  • Daniel Den Hoed Cancer Center at Erasmus Medical Center
    Rotterdam, 3008 AE, Netherlands
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
    Hull, England HU8 9HE, United Kingdom
  • Edinburgh Cancer Centre at Western General Hospital
    Edinburgh, Scotland EH4 2XU, United Kingdom
08

References and documents

Publications

  • 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. PubMed 21684151 ↗
  • 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. PubMed 20525721 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00227630
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Sep 28, 2005
Start date
Jul 2005
Primary completion
Aug 2007
Last update
Jul 18, 2012

Study contacts

Paul Van Schil, MD, PhD
study chair · University Hospital, Antwerp
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion