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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma  Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
For Condition: localized malignant mesothelioma,sarcomatous mesothelioma,advanced malignant mesothelioma,epithelial mesothelioma,recurrent malignant mesothelioma
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and kill them without harming normal cells. It is not yet known if combination chemotherapy is more effective with or without bevacizumab in treating malignant mesothelioma. PURPOSE: Randomizedphase II trial to compare the effectiveness of combination chemotherapy with or without bevacizumab in treating patients who have malignant mesothelioma.
Details: OBJECTIVES: - Compare the time to progression of patients with malignant mesothelioma treated with gemcitabine and cisplatin with or without bevacizumab. - Compare the objective response rate in patients treated with these regimens. - Compare the toxicity of these regimens when administered to these patients. - Compare the median and overall survival of patients treated with these regimens. - Assess plasma vascular endothelial growth factor and serum vascular cell adhesion molecule-1 levels before, during, and after study therapy as predictors of outcome in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to histology (epithelial vs other) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes (beginning after gemcitabine infusion) and bevacizumab IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), complete response (CR), or partial response (PR) after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats as in arm I. Patients who achieve SD, CR, or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression. PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma that is not amenable to curative surgery - Epithelial, sarcomatoid, or mixed subtype - Evidence of gross unresectability, including, but not limited to, the following conditions: - Direct extension into the chest wall - Mediastinal or hilar lymphadenopathy - Pulmonary or cardiac function that is inadequate to tolerate resection - Sarcomatoid or mixed histology - Pleural mesothelioma must be stage II or greater using the International Mesothelioma Interest Group staging system - Measurable disease outside prior irradiation port - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Pleural effusions and ascites are not considered measurable lesions - Site in pleura, lung, liver, or retroperitoneum that can be assessed by MRI for evaluation of blood flow - No obvious tumor involvement of major vessels by CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of bleeding diathesis Hepatic: - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal - INR no greater than 1.5 Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min - If 1+ or greater proteinuria on dipstick, then must have less than 500 mg of protein/24-hour urine collection - No significant renal impairment Cardiovascular: - See Disease Characteristics - No history of cerebrovascular accident or deep vein thrombosis - No myocardial ischemia or infarction or uncompensated coronary artery disease within the past 6 months - No uncontrolled hypertension - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary: - See Disease Characteristics - No history of pulmonary embolism Other: - No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other study agents - No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No ongoing or active infection - No other concurrent uncontrolled illness that would preclude study participation - No psychiatric illness or social situations that would preclude compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No growth factors for 24 hours before, during, or for 24 hours after cytotoxic chemotherapy Chemotherapy: - See Biologic therapy - Prior intrapleural cytotoxic agents (including bleomycin) allowed - No prior systemic cytotoxic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 6 weeks since prior major surgery Other: - At least 30 days since prior investigational drug - No other concurrent investigational or commercial agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 800-284-7370
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Joseph Clark 708-327-3236
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Marianna Koczywas 626-359-8111
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting James Stevenson 215-662-6682
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lee Krug 212-639-8420
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Charles Lu 713-792-6363
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-1000
United States
Recruiting Julie Brahmer 410-502-7159
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Stuart Wong 414-805-4603
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Pasi Janne 617-632-6076
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Hedy Kindler 773-702-0360
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting David Gandara 916-734-3772
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting Chandra Belani 412-648-6619
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting David Quinn 323-865-0456
City of Hope Medical Group *Recruiting*
Pasadena, California, 91105
United States
Recruiting Mark McNamara 626-396-2900
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Panos Fidias 617-726-9298
Additional Information:
Study ID Numbers: CDR0000069058; NCI-2710,UCCRC-11046A
Study Start Date:
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027703
Other Localized Malignant Mesothelioma Studies:
1. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
2. Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
3. Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
4. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
5. Capecitabine in Treating Patients With Malignant Mesothelioma
Related Studies:
Other localized malignant mesothelioma Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
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