|
Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Clinical research trials and Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery. Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery  Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
For Condition: localized malignant mesothelioma,advanced malignant mesothelioma,recurrent malignant mesothelioma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
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 if cisplatin is more effective with or without LY231514 for malignant mesothelioma of the pleura. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without LY231514 in treating patients who have malignant mesothelioma of the pleura that cannot be removed by surgery.
Details: OBJECTIVES: I. Compare survival in patients with malignant pleural mesothelioma when treated with cisplatin with or without LY231514. II. Compare duration of response, time to progression, and time to treatment failure in these patients with these treatment regimens. III. Compare tumor response rate and clinical benefit of these treatment regimens in these patients. IV. Compare Lung Cancer Symptom Scale scores, pulmonary function test scores, and lung density determinations with these treatment regimens in these patients. V. Compare toxicity of these treatment regimens in these patients. VI. Assess pharmacokinetics and vitamin metabolite status with these treatment regimens in these patients. PROTOCOL OUTLINE: This is a randomized, single blind, multicenter study. Patients are stratified according to performance status (Karnofsky 70-80% vs 90-100%), degree of measurability (bidimensional vs unidimensional only), histologic subtype (epithelial vs all others), WBC (8,300/mm3 and higher vs less than 8,300/mm3), pain intensity (low vs high), analgesic consumption (low vs high), dyspnea (low vs high), homocysteine (low vs high), gender, country, and treatment center. Patients are randomized to one of two treatment arms. Arm I: Patients receive LY231514 IV over 10 minutes followed by cisplatin IV over 2 hours on day 1. Arm II: Patients receive cisplatin as in arm I. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignant mesothelioma of the pleura not amenable to curative surgery; Must be radiologically accessible - Unidimensionally or bidimensionally measurable disease; Pleural effusions or positive bone scan not considered measurable - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: Prior immunomodulators allowed for pleurodesis; No concurrent immunotherapy - Chemotherapy: No prior systemic chemotherapy; At least 1 week since prior bleomycin for pleurodesis; Prior intracavitary cytotoxic drugs allowed for pleurodesis; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal anticancer therapy - Radiotherapy: At least 4 weeks since prior radiotherapy to target lesion; Lesion must be clearly progressive; No concurrent radiotherapy - Surgery: See Disease Characteristics; No concurrent surgery for cancer - Other: At least 4 weeks since any other prior investigational agent; No concurrent aspirin or other nonsteroidal antiinflammatory drug from 2 days prior to 2 days after study (5 days prior for long acting agents such as piroxicam, naproxen, diflunisal, or nabumetone); No other concurrent experimental medications --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase, AST, and ALT no greater than 3.0 times ULN (no greater than 5 times ULN with liver involvement); Albumin at least 3.0 g/dL - Renal: Creatinine clearance at least 45 mL/min - Other: No serious systemic disorders that may preclude study; No prior primary malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin; No obvious malnourishment or greater than 10% weight loss within 6 weeks prior to study; No active infection; Not pregnant or nursing; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidIlson, Study Chair, Memorial Sloan-Kettering Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Additional Information:
Study ID Numbers: CDR0000067791; MSKCC-99085,CWRU-LILY-1599,LILLY-H3E-MC-JMCH(a),NCI-G00-1767
Study Start Date: November 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005636
Other Advanced Malignant Mesothelioma Studies:
1. Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
2. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
3. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
4. Capecitabine in Treating Patients With Malignant Mesothelioma
5. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
Related Studies:
Other advanced malignant mesothelioma Clinical Trials
Other New Jersey Clinical Trials
Other New Brunswick Clinical Trials
Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
|
|
|
|
|
|
|
|
