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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01243632 |
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Date of registration:
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10/11/2010 |
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Primary sponsor: |
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Public title:
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Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
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Scientific title:
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A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma |
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Date of first enrolment:
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December 2002 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01243632 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Matjaz Zwitter, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Oncology Ljubljana |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven diagnosis of malignant pleural mesothelioma
- Inoperable for anatomic or physiological reason
- Measurable and previously unirradiated lesion
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
- Adequate haematopoietic, liver, and kidney function.
- Signed informed consent for participation in the trial
Exclusion Criteria:
- Significant medical co-morbidity
- Pregnant or lactating women
- History of the cancer in the previous 10 years or breast cancer ever.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malignant Pleural Mesothelioma
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Intervention(s)
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Drug: Prolonged 6-hr infusion of gemcitabine
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Primary Outcome(s)
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Response rate
[Time Frame: Computerized tomography (CT) measurement of disease will be performed after 2nd cycle of chemotherapy and at the end of the treatment]
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Secondary Outcome(s)
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Safety and tolerability
[Time Frame: During the study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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