Malignant MesotheliomaPhase 2ALIMESONCT00541073
Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
A Phase 2 study testing vitamin B12, cisplatin and pemetrexed disodium in people with Malignant Mesothelioma, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- vitamin B12, cisplatin and pemetrexed disodium
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed pleural mesothelioma
- Unresectable disease
- WHO performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
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- 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
- At least 28 days since prior radiotherapy (21 days for injected radiotherapy)
Who cannot join
- Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
- PATIENT CHARACTERISTICS:
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
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.
Read the 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.
- Conditions
- Malignant Mesothelioma
- Being tested
- vitamin B12, cisplatin, pemetrexed disodium, gene expression analysis, laboratory biomarker analysis
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B12Dietary supplement
cisplatinDrug
pemetrexed disodiumDrug
gene expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual dosage-adapted protocol
Secondary outcomes (3)
Relationship between pharmacokinetic and pharmacodynamic parameters
Pharmacokinetics
Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelie Lansiaux, MD, PhD, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541073
- Sponsor's protocol ID
- ALIMESO-0604
- Other IDs
- 2006-004573-95
- Acronym
- ALIMESO
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2007
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Pharmacological Study of Pemetrexed Administered With Cisplatin and a Vitamin Supplement in Patients With Nonresectable Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT00541073
- Acronym / sponsor ID
- ALIMESO / ALIMESO-0604
- Conditions
- Malignant Mesothelioma
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed pleural mesothelioma
- WHO performance status 0-2
- Life expectancy > 3 months
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Key exclusion criteria (10 listed)
- Clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures
- 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 chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin B12 | Dietary supplement | – |
| cisplatin | Drug | – |
| pemetrexed disodium | Drug | – |
| gene expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Individual dosage-adapted protocol
3 secondary outcomes
Relationship between pharmacokinetic and pharmacodynamic parameters
Pharmacokinetics
Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelie Lansiaux, MD, PhD
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vitamin B12, cisplatin and pemetrexed disodium in people with Malignant Mesothelioma, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual dosage-adapted protocol. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.