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Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Clinical research trials and Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed clinical trial. Test subjects typically obtain the finest healthcare available for their Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed  Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
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. PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiuseppeGiaccone, Study Chair, EORTC Lung Cancer Cooperative Group
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Ospedale Bellaria
Bologna, , I-40139
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, , 16132
Italy
Vrije Universiteit Medisch Centrum
Amsterdam, , 1117 MB
Netherlands
Universita Degli Studi di Udine
Udine, , 33100
Italy
Additional Information:
Study ID Numbers: CDR0000067501; EORTC-08992
Study Start Date: November 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004254
Other Advanced Malignant Mesothelioma Studies:
1. Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
2. ZD 1839 in Treating Patients With Malignant Mesothelioma
3. Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
4. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
5. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
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Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
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