Malignant Mesothelioma Clinical Trial
Official title:
Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
Verified date | July 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Centre Oscar Lambret | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Individual dosage-adapted protocol | No | ||
Secondary | Relationship between pharmacokinetic and pharmacodynamic parameters | No | ||
Secondary | Pharmacokinetics | No | ||
Secondary | Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD) | No |
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