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

NCT ID: NCT01397305

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-14
• Study Completion Date: 2014-10-16

Brief 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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modufolin and Pemetrexed

Modufolin ( \[6R\] 5,10-methylenetetrahydrofolate) and Pemetrexed

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.

Pemetrexed

Intervention Type: DRUG

500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.

Interventions

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

10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.

Intervention Type: DRUG

Pemetrexed

500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.

Intervention Type: DRUG

Other Intervention Names

Modufolin; 6R-MTHF; ISO-901; arfolitixorin; ly 231514; multitargeted antifolate

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isofol Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bengt G Gustavsson, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

ISO-MC-091

Identifier Type: -

Identifier Source: org_study_id