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Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

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Trial Information

Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma



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


- 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.

Inclusion Criteria


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


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


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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Individual dosage-adapted protocol

Safety Issue:


Principal Investigator

Amelie Lansiaux, MD, PhD

Investigator Affiliation:

Centre Oscar Lambret


United States: Federal Government

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma