A Phase 2 interventional study of pemetrexed/platinum chemotherapy and Pemetrexed/platinum chemotherapy in Malignant Pleural Mesothelioma, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-14.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
The prognosis of mesothelioma is generally poor. The median survival of patients with unresectable malignant mesothelioma ranges approximately between 6-12 months. Survival is poor because there is no curative treatment.
Treatment options include surgery, chemotherapy and radiotherapy. Recently multimodality treatment regimens have been reported to prolong survival. Other new therapeutic approaches include immunotherapy, gene therapy, hyperthermic chemoperfusion of the pleura and photodynamic therapy, but the results have not yet been completely validated. Even with the introduction of this new therapeutic protocol, the response does not exceed 41%, with a mean survival of 12 months. The current standard of care for unresectable malignant pleural mesothelioma is pemetrexed/cisplatin. This regimen was compared to cisplatin alone in a study including 448 patients from 19 countries which was the largest trial to date among patients suffering from malignant mesothelioma. Results showed statistically significant increase in overall survival by about 30 % (12.1 months for pemetrexed /cisplatin versus 9.3 months for cisplatin alone. In addition, there was an improvement in lung function (forced vital capacity) in the pemetrexed /cisplatin arm in comparison to the cisplatin arm.
Until now, however, there is no consensus on the number of cycles of pemetrexed/cisplatin in malignant mesothelioma and there are no approved predictive markers for response.
Pemetrexed/cisplatin regimen is an expensive regimen and associated with considerable toxicity and so we need to rationalize its use in our Egyptian patients.
Therefore, the investigators aim in this work to compare 4 cycles versus 6 cycles of pemetrexed/cisplatin in malignant mesothelioma and to identify a predictive marker for response.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's planned enrollment of 70 is above the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Four cycles of pemetrexed/platinum
Drug: pemetrexed/platinum chemotherapy
Six cycles of pemetrexed/platinum
Drug: Pemetrexed/platinum chemotherapy
Four cycles of pemetrexed/platinum chemotherapy
Six cycles of pemetrexed/platinum chemotherapy
Progression free survival
Time frame: one year
Overall survival
Time frame: 3 years
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Ain Shams University