Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Supportive care, Treatment	Active	18 and over	Other	COL-ALIMESO ALIMESO, INCA-RECF0441, COL-2006-04, NCT00541073

Objectives

Primary

1. Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.

Secondary

1. Determine the relationship between pharmacokinetic and pharmacodynamic parameters (hematologic and nonhematologic).
2. Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium.
3. Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the toxicity of pemetrexed disodium.
4. Validate a strategy of adapting dosage.

Entry 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

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

Patient Characteristics:

Inclusion criteria:

• WHO performance status 0-2
• Life expectancy > 3 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Individual dosage-adapted protocol

Relationship between pharmacokinetic and pharmacodynamic parameters
Pharmacokinetics
Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)

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.

Trial Contact Information

Trial Lead Organizations

Centre Oscar Lambret

Amelie Lansiaux, MD, PhD, Study coordinator		Ph: 33-32-029-5953

France
	Lille
	Centre Oscar Lambret
		Amelie Lansiaux, MD, PhD	Ph:  33-32-029-5953

Registry Information
Official Title		Phase 2 pharmacological study of pemetrexed administered with cisplatin and a vitamin supplement in patients with nonresectable pleural mesothelioma
Trial Start Date		2007-06-18
Registered in ClinicalTrials.gov		NCT00541073
Date Submitted to PDQ		2007-08-20
Information Last Verified		2009-07-05

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