- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869023
Phase II Study of Six Hours Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma
Phase II Study of Six Hours, Low Dose Gemcitabine Plus Cisplatin in the Treatment for Advanced Pleural Mesothelioma.
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.
Primary Objective.
-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.
Secondary objectives.
- 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.
Hypothesis:
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico
- Instituto Nacional de Cancerologia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologic Diagnosis of Pleural Mesothelioma
- Multidisciplinary assessment and considered not candidate for resection.
- Karnofsky > = 70 or ECOG < 2
- Adequate Hematologic, renal and hepatic function.
Exclusion Criteria:
- Superior vena cava syndrome, severe bone pain or CNS metastasis
- Not candidate for chemotherapy (Poor functional status: ECOG > 2)
- The patient refuses to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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 Names:
Cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate adverse effects to 250 mg/m2 infusion gemcitabine
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: 2 years
|
2 years
|
overall survival
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- INCANOGAR2012-JA3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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