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Home > "C" Clinical Trials Conditions > Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura  Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
For Condition: recurrent malignant mesothelioma,advanced malignant mesothelioma,localized malignant mesothelioma
Status: No longer recruiting
Sponsor(s): EORTC Lung Cancer Cooperative Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JanMeerbeeck, Study Chair, University Hospital - Rotterdam Dijkzigt
Kantonsspital - St. Gallen
St. Gallen, , CH-9007
Switzerland
Hopital Charles Nicolle
Rouen, , 76031
France
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Medical University of Gdansk
Gdansk, , 80-211
Poland
Hopital de la Conception
Marseille, , 13385
France
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
National Cancer Institute of Egypt
Cairo, ,
Egypt
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Inselspital, Bern
BERN, , CH-3010
Switzerland
Thoraxklinik Rohrbach
Heidelberg, , D-69126
Germany
Erasmus Medical Center
Rotterdam, , 3075 EA
Netherlands
University Hospital
Basel, , CH-4031
Switzerland
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Instituto de Enfermedades Neoplasicas
Lima, , 34
Peru
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , 13274
France
McGill University
Montreal, Quebec, H2W 1S6
Canada
Regional Lung Diseases Hospital
Poznan, , 60 569
Poland
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
University Hospital - Rotterdam Dijkzigt
Rotterdam, , 3000 CA
Netherlands
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Additional Information:
Study ID Numbers: CDR0000067603; EORTC-08983
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004920
Other Recurrent Malignant Mesothelioma Studies:
1. Capecitabine in Treating Patients With Malignant Mesothelioma
2. Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
3. ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
4. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
5. Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
Related Studies:
Other recurrent malignant mesothelioma Clinical Trials
Other Scotland Clinical Trials
Other Edinburgh Clinical Trials
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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