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

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ClinicalTrials.gov Identifier: NCT00541073
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Individual dosage-adapted protocol

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541073


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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OverallOfficial: Amelie Lansiaux, MD, PhD Centre Oscar Lambret
More Information
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ClinicalTrials.gov Identifier: NCT00541073    
Other Study ID Numbers: CDR0000564058
COL-ALIMESO
INCA-RECF0441
COL-2006-04
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma
recurrent malignant mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Vitamin B 12
Hydroxocobalamin
Cisplatin
Pemetrexed
Vitamins
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Vitamin B Complex
Hematinics