AzTrials
AzTrials

Malignant MesotheliomaPhase 2NCT00227630

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

A Phase 2 study testing cisplatin, pemetrexed disodium and adjuvant therapy in people with Malignant Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 69 years
Conditions the study is for
Malignant Mesothelioma
What is being tested?
cisplatin, pemetrexed disodium and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
59 participants
Where
8 sitesin 4 countries
Study dates
Jul 2005to Aug 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 69 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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])

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Italy3 sites

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

  • Azienda Ospedaliera Di Parma

    Parma, 43100

  • Universita Degli Studi di Udine

    Udine, 33100

Other trials in Italy

Netherlands2 sites

  • Sint Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

Other trials in Netherlands

United Kingdom2 sites

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust

    Hull, England, HU8 9HE

Other trials in United Kingdom

Belgium1 site

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

Other trials in Belgium

About this study

Official title: A Phase II Feasibility Trial of Induction Chemotherapy Followed by Extrapleural Pneumonectomy and Postoperative Radiotherapy in Patients With Malignant Pleural Mesothelioma

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.

Keywords
epithelial mesothelioma, sarcomatous mesothelioma, localized malignant mesothelioma, recurrent malignant mesothelioma
Medical subject headings
Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

  1. Toxicity

  2. Progression-free survival

  3. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00227630
Sponsor's protocol ID
EORTC-08031
Other IDs
EORTC-08031, 2004-004273-28, 2004
Status last verified
Jul 2012
First submitted
26 Sep 2005
Last updated
18 Jul 2012
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, pemetrexed disodium and adjuvant therapy in people with Malignant Mesothelioma, run by European Organisation for Research and Treatment of Cancer - EORTC at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy, Netherlands, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility in terms of 90-day progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00227630, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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