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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004920
Other study ID # EORTC-08983
Secondary ID EORTC-08983
Status Completed
Phase Phase 3
First received March 7, 2000
Last updated July 17, 2012
Start date November 1999

Study information

Verified date July 2012
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.


Description:

OBJECTIVES:

- Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin.

- Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients.

- Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease.

OUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms.

- Arm I: Patients receive cisplatin IV over 1-2 hours on day 1.

- Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1.

Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year.

Patients are followed every 6 weeks until death.

PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 256
Est. completion date
Est. primary completion date January 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed malignant pleural mesothelioma

- No CNS metastases

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ZUBROD, ECOG, WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 10.0 g/dL

- WBC at least 4,000/mm^3

- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 1.46 mg/dL

- Albumin at least 3.0 g/dL

- ALAT/ASAT 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

Cardiovascular:

- Not specified

Pulmonary:

- Not specified

Other:

- No other prior or concurrent malignancies within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin

- No prior malignant melanoma, hypernephroma or breast carcinoma

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study

- No uncontrolled infections

- No psychological, familial, sociological, or geographical condition that precludes study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunotherapy before first disease progression

Chemotherapy:

- No prior systemic or intracavitary cytotoxic chemotherapy

- No other prior or concurrent chemotherapy before first disease progression

- No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)

Endocrine therapy:

- No concurrent hormonal therapy except corticosteroids before first disease progression

Radiotherapy:

- At least 4 weeks since prior radiotherapy to target lesion and progression observed

- Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field

Surgery:

- Prior surgery allowed if followed by disease progression

Other:

- At least 1 month since prior investigational drugs

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
cisplatin

raltitrexed


Locations

Country Name City State
Belgium U.Z. Gasthuisberg Leuven
Canada Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Trillium Health Centre Mississauga Ontario
Canada McGill University Montreal Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Princess Margaret Hospital Toronto Ontario
Egypt National Cancer Institute of Egypt Cairo
France Assistance Publique Hopitaux de Marseille Hopitaux Sud Marseille
France Hopital de la Conception Marseille
France Hopital Charles Nicolle Rouen
Germany Thoraxklinik Rohrbach Heidelberg
Italy Istituto Nazionale per la Ricerca sul Cancro Genoa (Genova)
Netherlands University Medical Center Nijmegen Nijmegen
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Hospital - Rotterdam Dijkzigt Rotterdam
Netherlands Academisch Ziekenhuis Utrecht Utrecht
Peru Instituto de Enfermedades Neoplasicas Lima
Poland Medical University of Gdansk Gdansk
Poland Regional Lung Diseases Hospital Poznan
Switzerland University Hospital Basel
Switzerland Inselspital, Bern Bern
Switzerland Kantonsspital - St. Gallen St. Gallen
United Kingdom Western General Hospital Edinburgh Scotland
United Kingdom Nottingham City Hospital NHS Trust Nottingham England
United Kingdom Weston Park Hospital Sheffield England

Sponsors (1)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Canada,  Egypt,  France,  Germany,  Italy,  Netherlands,  Peru,  Poland,  Switzerland,  United Kingdom, 

References & Publications (5)

Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EO — View Citation

Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international — View 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. — View Citation

van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized — View Citation

Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Cl

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