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Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma Clinical research trials and Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma. Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma  Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
For Condition: sarcomatous mesothelioma,epithelial mesothelioma,advanced malignant mesothelioma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have pleural or peritonealmalignant mesothelioma.
Details: OBJECTIVES: - Determine the objective tumor response rate in chemotherapy-naïve patients with malignant pleural mesothelioma treated with pemetrexed disodium and gemcitabine. - Determine the median survival of patients with malignant pleural or peritoneal mesothelioma treated with this regimen. - Determine the time to objective tumor response and duration of response in patients treated with this regimen. - Determine the time to treatment failure in patients treated with this regimen. - Determine the time to progressive disease in patients treated with this regimen. - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the quantitative and qualitative toxic effects of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days and then every 3 months. PROJECTED ACCRUAL: A total of 18-73 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant pleural or peritoneal mesothelioma of 1 of the following subtypes: - Epithelial - Sarcomatoid - Mixed subtype - Disease not amenable to curative surgery - Measurable disease - At least 1 measurable lesion at least 20 mm by conventional techniques or at least 10 mm by spiral CT scan - At least 1 level on lesion scan must have 1 pleural rind measurement at least 15 mm - If there is only 1 measurable lesion, the neoplastic nature must be histologically confirmed - Clinically detected lesions are only considered measurable if superficial (e.g., skin nodules and palpable lymph nodes) - The following are not considered measurable disease: - Pleural effusions - Positive bone scans - No known or suspected brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN* - ALT and AST no greater than 3 times ULN* - Albumin at least 2.5 g/dL NOTE: *No greater than 5 times ULN in the case of liver involvement by tumor Renal - Creatinine clearance at least 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No active infection - No concurrent serious systemic disorders (including oncologic emergencies) that would preclude study participation - No other currently active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix (patients with previously treated malignancy are eligible if at less than 30% risk of relapse) - Able to tolerate folic acid or cyanocobalamin administration PRIOR CONCURRENT THERAPY: Biologic therapy - No prior intracavitary immunomodulators, unless given for pleurodesis - No filgrastim (G-CSF) within 24 hours of study chemotherapy administration - No concurrent immunotherapy - No concurrent routine colony-stimulating factor therapy - No concurrent stimulators of thrombopoiesis Chemotherapy - No prior systemic chemotherapy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy for cancer Radiotherapy - Prior radiotherapy to the target lesion allowed provided the lesion has clearly progressed - At least 4 weeks since prior radiotherapy - No concurrent non-palliative radiotherapy Surgery - No concurrent surgery for cancer Other - At least 2 weeks since prior pleurodesis - No prior intracavitary cytotoxic drugs, unless given for pleurodesis - More than 4 weeks since prior investigational agents - No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 days of pemetrexed disodium administration - No long-acting NSAIDs (e.g., naproxen, piroxicam, diflunisal, nabumetone, rofecoxib, or celecoxib) within 5 days of pemetrexed disodium administration - No other concurrent experimental medications (except thymidine)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AfshinDowlati, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Afshin Dowlati 216-844-1228
Additional Information:
Study ID Numbers: CDR0000299535; CWRU-LILY-1502,LILLY-H3E-US-JMFZ(b)
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060190
Other Epithelial Mesothelioma Studies:
1. Cisplatin With or Without LY231514 in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery
2. PTK787/ZK 222584 in Treating Patients With Unresectable 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. Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung
5. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
Related Studies:
Other epithelial mesothelioma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma
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