← Human Trials & Peer-Reviewed Studies
Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery
Plain-language guide to NCT00541073: phase 2 non-randomized trial of Cyanocobalamin (Vitamin B12), 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00541073
- Phase
- phase 2
- Status
- completed
- Start
- 2007-06
- Completion (planned or actual)
- 2011-05
- Participants
- 60 (estimated)
- Design
- non-randomized, treatment
- Conditions studied
- Malignant Mesothelioma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).
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.
The registry classes the interventions as dietary supplement, drug, genetic and other.
More on the Plan
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.
Who Took Part
Enrollment: 60 planned participants were the target.
It was open to people of any sex aged from 18 years up to 120 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Histologically confirmed pleural mesothelioma.
The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: clinically detected pleural effusion or ascites that cannot be controlled by drainage or other procedures; WHO performance status 0-2; life expectancy \> 3 months.
How the Study Was Run
It was run as a non-randomized study.
It started in 2007-06 with completion listed for 2011-05.
It ran at 1 site in France.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2, non-randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.