search
Back to results

Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
raltitrexed
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 localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

Eligibility Criteria

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

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

Sites / Locations

  • Ospedale Bellaria
  • Istituto Nazionale per la Ricerca sul Cancro
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Universita Degli Studi di Udine
  • Antoni van Leeuwenhoekhuis
  • Vrije Universiteit Medisch Centrum

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
search

1. Study Identification

Unique Protocol Identification Number
NCT00004254
Brief Title
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Official Title
Phase II Study on Tomusex in Malignant Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
June 2001 (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 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.
Detailed Description
OBJECTIVES: I. Determine the therapeutic activity and toxicities of raltitrexed in patients with inoperable malignant mesothelioma. II. Determine the objective response rate and duration of response in patients treated with this regimen. OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival. PROJECTED ACCRUAL: A total of 24 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
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
raltitrexed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giaccone, MD, PhD
Organizational Affiliation
Free University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
I-40139
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Universita Degli Studi di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1117 MB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16809726
Citation
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.
Results Reference
background
PubMed Identifier
12565988
Citation
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.
Results Reference
result

Learn more about this trial

Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed

We'll reach out to this number within 24 hrs