NCT00004254

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2001

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

January 28, 2000

Last Update Submit

July 17, 2012

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesotheliomaadvanced malignant mesotheliomarecurrent malignant mesothelioma

Interventions

raltitrexedDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven inoperable malignant mesothelioma All tumor stages eligible At least 1 target lesion with measurable disease in at least 1 dimension (20 cm or more with conventional techniques OR 10 cm or more with spiral CT scans) Outside irradiated field Prior surgery allowed if evidence of disease progression thereafter No signs or symptoms of CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ZUBROD/ECOG/WHO 0-2 (after palliative measures such as pleural drainage) Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10.0 g/dL WBC at least 4,000/mm3 Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.46 mg/dL Albumin at least 3.0 g/dL ALT and AST less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver involvement) Renal: Creatinine less than 1.69 mg/dL Creatinine clearance at least 65 mL/min Other: No other malignancies (including melanoma, hypernephroma, or breast carcinoma) within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled infection No psychologic, familial, sociologic, or geographic condition that could interfere with compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy before first disease progression Chemotherapy: No prior systemic or intracavitary cytotoxic drugs No concurrent intrapleural or other systemic cytotoxic drugs Endocrine therapy: No concurrent anticancer hormonal agents (except corticosteroids) before first disease progression Radiotherapy: See Disease Characteristics Concurrent palliative radiotherapy allowed for painful lesions, needle tracts, or surgical scars or prevention of metastases along biopsy tracks At least 4 weeks since prior radiotherapy No prior radiotherapy to sole indicator lesion unless lesion is clearly progressive Surgery: See Disease Characteristics Prior pleurodesis allowed except with cytotoxic drugs (e.g., bleomycin) Concurrent pleurodesis with noncytotoxic drugs allowed Other: At least 1 month since other prior investigational agent No other concurrent anticancer agents before first disease progression

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Ospedale Bellaria

Bologna, I-40139, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Naples, 80131, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1117 MB, Netherlands

Location

Related Publications (2)

  • Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol. 2006 Jul 1;24(19):3007-12. doi: 10.1200/JCO.2005.05.1359.

    PMID: 16809726BACKGROUND

  • Baas P, Ardizzoni A, Grossi F, Nackaerts K, Numico G, Van Marck E, van de Vijver M, Monetti F, Smid-Geirnaerdt MJ, van Zandwijk N, Debruyne C, Legrand C, Giaccone G; EORTC Lung Cancer Group. The activity of raltitrexed (Tomudex) in malignant pleural mesothelioma: an EORTC phase II study (08992). Eur J Cancer. 2003 Feb;39(3):353-7. doi: 10.1016/s0959-8049(02)00668-8.

    PMID: 12565988RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

raltitrexed

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Giuseppe Giaccone, MD, PhD

    Free University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

April 23, 2004

Study Start

November 1, 1999

Primary Completion

June 1, 2001

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

IT(4)NL(2)