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Modufolin® in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

Information source: Isofol Medical AB
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Neoplasm

Intervention: Modufolin (Drug); Fluorouracil (Drug); Oxaliplatin (Drug); Irinotecan (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Isofol Medical AB

Official(s) and/or principal investigator(s):
Helena Taflin, MD, Principal Investigator, Affiliation: Sahlgrenska University Hospital, Sweden

Overall contact:
Louise Kvistgaard, Phone: +46 (0) 707 505 567, Email: louise.kvistgaard@isofolmedical.com

Summary

The purpose is to characterise the tolerability of Modufolin in combination with 5-FU, in combination with 5-FU and Oxaliplatin and in combination with 5-FU and Irinotecan. Another purpose is to investigate 2 doses of Modufolin to identify the best dose for further assessment.

Clinical Details

Official title: An Open-label, Multiple-site, Phase I/II Dose Cohort Trial of [6R] 5,10-Methylene Tetrahydrofolate (Modufolin) in Combination With a Fixed Dose of 5-Fluorouracil (5-FU) Alone or Together With a Fixed Dose of Oxaliplatin or Irinotecan in Patients With Stage IV Colorectal Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Frequency and severity of dose limiting toxicity (DLT) or other Adverse Events (AE)

Number of patients with adjusted chemotherapeutic agent dose due to presence of dose related toxicity

Secondary outcome:

Number and severity of AEs or abnormal laboratory test

CT scan or MRI

Deoxyuridine (dU) levels before and 24 hours after treatment in a subset of patients

Analyse of levels of 5,10- MTHF, 5-methyl-THF, and THF in a subset of patients

Detailed description: The study will investigate the tolerability of Modufolin at two (2) dose levels (30 and 60 mg/m2) in three (3) treatment combinations of the chemotherapeutic agents 5-FU, Oxaliplatin and Irinotecan during eight (8) weeks of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Advanced metastatic colorectal (Stage IV) cancer verified by biopsy 2. CT-scan or MRI of thorax, abdomen and pelvis; within four (< 4) weeks before start of chemotherapy 3. Evaluable disease and one measurable site of disease according to RECIST 1. 1 criteria (at least 10 mm for CT-scan or MRI) 4. Male and female adults, age of 18 years or older 5. WHO performance status 0 < 2, and life expectancy > 3 months 6. Adequate haematological function: 1. Haemoglobin (Hb) > 100 g/L, 2. Absolute neutrophil count (ANC) > 1. 5x109/L, and 3. Platelets > 100x109/L 7. Adequate renal and hepatic functions: 1. Creatinine clearance > 50 mL/min, 2. Total bilirubin < 1. 5 times upper limit of normal (ULN), 3. Aspartate transaminase (AST) and Alanine transaminase (ALT) < 3 times ULN (and < 5 times ULN in case of liver metastases) 8. Negative pregnancy test for females of child bearing potential 9. Willing and able to provide informed consent 10. Using adequate contraceptive measures Exclusion Criteria: 1. Tumours other than colorectal adenocarcinomas (current or within the previous 5 years), with the exception for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix. 2. Adjuvant treatment of CRC within the last 12 months. 3. Evidence of central nervous system metastases 4. Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn's disease or ulcerative colitis 5. History of cardiac disease with a New Your Heart Association (NYHA) Class II or greater congestive heart failure, myocardial infarction or unstable angina in the past six (6) months prior to Day 1 of treatment and serious arrhythmias requiring medication for treatment 6. Current severe chronic diarrhoea 7. Current chronic infection or uncontrolled serious illness causing immunodeficiency 8. Any current uncontrolled serious illness or medical condition 9. Current major psychiatric disorder (e. g. major depression, psychosis) 10. Participation in another clinical study with an IMP within one (1) month prior to inclusion 11. Known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency 12. Suspicion of hypersensitivity or allergy to the IMP, or to products chemically related to the IMP (i. e. folate derivatives) 13. Female patients: currently pregnant or breast-feeding.

Locations and Contacts

Louise Kvistgaard, Phone: +46 (0) 707 505 567, Email: louise.kvistgaard@isofolmedical.com

Oslo University Hospital, Oslo, Norway; Not yet recruiting
Tormod Guren, MD
Tormod Guren, MD, Principal Investigator

Sahlgrenska University Hospital, Gothenburg 461 85, Sweden; Recruiting
Hillevi Björkqvist, RN, Phone: +46 31 343 66 57, Email: hillevi.bjorkqvist@vgregion.se
Helena Taflin, MD, Principal Investigator

Additional Information

Starting date: September 2014
Last updated: May 13, 2015

Page last updated: August 20, 2015

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