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

• Status: Completed
• Trial end date: 2014-10-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isofol Medical AB
• Treatments: Antimetabolites; Antimetabolites, Antineoplastic; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pemetrexed; Tetrahydrofolates

Criteria

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• Have previously completed or withdrawn from this study or any other study investigating pemetrexed.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