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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: October 5, 2007
Last updated: May 14, 2011
Last verified: July 2009

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.

Condition Intervention Phase
Malignant Mesothelioma Dietary Supplement: vitamin B12 Drug: cisplatin Drug: pemetrexed disodium Genetic: gene expression analysis Other: laboratory biomarker analysis Other: pharmacological study Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Individual dosage-adapted protocol

Secondary Outcome Measures:
  • Relationship between pharmacokinetic and pharmacodynamic parameters
  • Pharmacokinetics
  • Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)

Estimated Enrollment: 60
Study Start Date: June 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00541073

Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
OverallOfficial: Amelie Lansiaux, MD, PhD Centre Oscar Lambret
  More Information Identifier: NCT00541073     History of Changes
Other Study ID Numbers: CDR0000564058
Study First Received: October 5, 2007
Last Updated: May 14, 2011

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Hematinics processed this record on August 21, 2017