Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma
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|ClinicalTrials.gov Identifier: NCT01869023|
Recruitment Status : Unknown
Verified March 2017 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was: Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : March 3, 2017
Malignant pleural mesothelioma (MPM) is a rare disease, but with a very high mortality. MPM is frequently found in advanced stages. The standard treatment in advanced pleural mesothelioma is cisplatin-based chemotherapy combined with pemetrexed/raltitrexed (phase III studies showed its benefit in response and overall survival compared with cisplatin alone). There are other active drugs such as liposomal doxorubicin and gemcitabine. Unfortunately, cost is an important factor to consider in our population and standard treatments are very expensive. Gemcitabine 250 mg infused over 6 hrs in combination with cisplatin, compared to the standard administration of gemcitabine 1250 mg infusion of 30 minutes in NSCLC, combined with cisplatin showed 75 mg shown in a study to be equally effective in treating cancer non-small cell lung. A phase II study using this strategy for advanced MPM has shown promising results. Gemcitabine administered in low dose in a six hour infusion may reduce cost of treatment without altering the effectiveness.
-Evaluate the response of treatment with gemcitabine at a dose of 250 mg/m2SC in 6-hour infusion combined with cisplatin in patients with unresectable malignant mesothelioma.
- Evaluate toxicity of the combination of gemcitabine at a dose of 250 mg/m2 infused over 6 hours in with cisplatin in patients with unresectable malignant mesothelioma.
- Evaluate the progression free survival (PFS) and overall survival (OS) in patients with unresectable MM treated with this combination.
Combination therapy of gemcitabine at a dose of 250 mg/m2 infusion of 6 hrs applied on day 1 and 8 combined with cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles is a treatment that provides similar results in responses when compared with previous studies with the same combination therapy, but with a conventional administration (gemcitabine 1,250 mg in 30 minutes on days 1, 8 and 15).
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Pleural Mesothelioma||Drug: Gemcitabine Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Six Hours, Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma.|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
6 h infusion Gemcitabine and Cisplatin
Gemcitabine 250 mg/m2 Cisplatin 30 mg/m2
Combination of Gemcitabine 250 mg/m2 in six hour infusion with cisplatin 35 mg/m2 administered day 1 and 8, for six cycles.
Other Name: Gemzar
Cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles
Other Name: Platinol
- Evaluate adverse effects to 250 mg/m2 infusion gemcitabine [ Time Frame: 2 years ]
- Progression Free Survival [ Time Frame: 2 years ]
- overall survival [ Time Frame: 2 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): NCT01869023
|Instituto Nacional de Cancerología|
|Mexico City, Mexico|
|Principal Investigator:||Oscar Arrieta, MD||Instituto de Cancerología|