A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
Status and phase
Completed
Phase 3
Conditions
Mesothelioma
Treatments
Drug: Pemetrexed
Details and patient eligibility
About
Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Histologically proven diagnosis of mesothelioma of the pleura.
- received only one prior systemic chemotherapy regimen for advanced or metastatic disease
- Performance status of 70 or higher on the Karnofsky Performance Status Scale
- Males or females at least 18 years of age
- Adequate organ function
Exclusion criteria
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Pregnancy or breastfeeding
- Brain metastasis
- Prior treatment with Pemetrexed
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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