Four Versus Six Cycles of Pemetrexed/Platinum for MPM
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|ClinicalTrials.gov Identifier: NCT02497053|
Recruitment Status : Unknown
Verified July 2015 by Omar Abdel-Rahman, Ain Shams University.
Recruitment status was: Recruiting
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: pemetrexed/platinum chemotherapy Drug: Pemetrexed/platinum chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Four Versus Six Cycles of Pemetrexed/Platinum as a First Line Treatment of Malignant Pleural Mesothelioma; a Randomized Phase II Study|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2016|
Experimental: Arm A
Four cycles of pemetrexed/platinum
Drug: pemetrexed/platinum chemotherapy
Four cycles of pemetrexed/platinum chemotherapy
Active Comparator: Arm B
Six cycles of pemetrexed/platinum
Drug: Pemetrexed/platinum chemotherapy
Six cycles of pemetrexed/platinum chemotherapy
- Progression free survival [ Time Frame: one year ]
- Overall survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497053
|Contact: Omar Abdel-Rahman, MDfirstname.lastname@example.org|
|Principal Investigator:||Omar Abdel-Rahman, MD||Ain Shams University|