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Mesothelioma Related Clinical Trials:
Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Recruiting
Sponsors and Collaborators: Centre Oscar Lambret
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00541073
Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: pemetrexed disodium; Drug: vitamin B12; Procedure: chemoprotection; Procedure: chemotherapy; Procedure: diagnostic procedure; Procedure: enzyme inhibitor therapy; Procedure: gene expression analysis; Procedure: laboratory biomarker analysis; Procedure: pharmacological study
Purpose:
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery.
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma |
- Individual dosage-adapted protocol [ Designated as safety issue: No ]
- Relationship between pharmacokinetic and pharmacodynamic parameters [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD) [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2007 |
Detailed Description:
OBJECTIVES:
Primary
- Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.
Secondary
- Determine the relationship between pharmacokinetic and pharmacodynamic parameters (hematologic and nonhematologic).
- Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium.
- Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the toxicity of pemetrexed disodium.
- Validate a strategy of adapting dosage.
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive vitamin B12 intramuscularly on day -7 and then every 9 weeks until chemotherapy is completed.
Blood samples are collected during the first and third courses of chemotherapy. Samples are analyzed by pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, xPD), pharmacokinetic, and other pharmacological methods.
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
-
Histologically confirmed pleural mesothelioma
- Unresectable disease
Exclusion criteria:
- Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine clearance > 45 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN (5 times ULN if liver metastases)
- Not pregnant or nursing
- Fertile patients of must use effective contraception during and for 6 months after completion of study treatment
Exclusion criteria:
- Hypersensitivity to pemetrexed disodium or any of its excipients
- Peripheral neuropathy ≥ grade 2
- Impossible to receive study therapy due to geographical, social, familial, or psychological reasons
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- At least 28 days since prior radiotherapy (21 days for injected radiotherapy)
Exclusion criteria:
- Prior chemotherapy
- Prior yellow fever vaccine
- Inability to discontinue aspirin (> 1.3 g/day) or NSAIDs for 2 days prior to, during, and 2 days after day 1 of each course of study therapy
- Concurrent participation in another clinical study
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541073Locations
| France | |||||
| Centre Oscar Lambret | Recruiting | ||||
| Lille, France, 59020 | |||||
| Contact: Amelie Lansiaux, MD, PhD 33-32-029-5953 | |||||
Sponsors and Collaborators
| Centre Oscar Lambret |
Investigators
| Investigator: | Amelie Lansiaux, MD, PhD | Centre Oscar Lambret |
Additional Information:
| Study ID Numbers: Â | CDR0000564058, COL-ALIMESO, INCA-RECF0441, COL-2006-04 |
| First Received: Â | October 5, 2007 |
| Last Updated: Â | December 25, 2007 |
| ClinicalTrials.gov Identifier: Â | NCT00541073 |
| Health Authority: Â | Unspecified |
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