An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

Isofol Medical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Rectal Cancer

Treatments

Drug: Pemetrexed

Drug: [6R] 5,10-methylenetetrahydrofolate (arfolitixorin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01397305

ISO-MC-091

Details and patient eligibility

About

The purpose of this study is to determine whether an optimal dose of [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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Have previously completed or withdrawn from this study or any other study investigating pemetrexed.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.