An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
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Keep this study
Lead
Isofol Medical AB
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pathological/ cytological diagnosis of adenocarcinoma of the rectum. Patients must have operable rectal cancer that is amenable to surgery.
No prior therapy for rectal cancer
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
Adequate organ function
Patient compliance and geographic proximity that allow adequate follow-up
For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test and must not be lactating.
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
Estimated life expectancy of at least 12 weeks
Signed informed consent
At least 18 years of age
You may not be if
Concurrent administration of any other anti-tumor therapy.
Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.
Have previously completed or withdrawn from this study or any other study investigating pemetrexed.
Are pregnant or breast-feeding.
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
History of significant neurological or mental disorder, including seizures or dementia.
Inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (NSAIDs)
Presence of clinically relevant third-space fluid collection that cannot be controlled by drainage or other procedures prior to study entry.
Inability or unwillingness to be given 5,10-methylenetetrahydrofolate, vitamin B12 or dexamethasone.
Clareo Health | An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
