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

NCT00541073 | Completed Phase 2

• 4 other identifiers: CDR0000564058COL-ALIMESOINCA-RECF0441COL-2006-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Mesothelioma

Keywords

advanced malignant mesothelioma; recurrent malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Individual dosage-adapted protocol

Secondary Outcomes (3)

• Relationship between pharmacokinetic and pharmacodynamic parameters

• Pharmacokinetics

• Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)

Interventions

vitamin B12 DIETARY_SUPPLEMENT

cisplatin DRUG

pemetrexed disodium DRUG

gene expression analysis GENETIC

laboratory biomarker analysis OTHER

pharmacological study OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed pleural mesothelioma
• Unresectable disease

You may not qualify if:

• Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
• PATIENT CHARACTERISTICS:
• 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
• 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:

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Vitamin B 12; Cisplatin; Pemetrexed; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Genetic Techniques; Investigative Techniques

Study Officials

• Amelie Lansiaux, MD, PhD

  Centre Oscar Lambret

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2009-07

Locations

FR (1)