PK/PD Investigation of Modufolin® in Plasma, Tumor and Adjacent Mucosa in Patients With Colon Cancer
This study is currently recruiting participants.
Verified September 2012 by Isofol Medical AB
Sponsor:
Isofol Medical AB
Information provided by (Responsible Party):
Isofol Medical AB
ClinicalTrials.gov Identifier:
NCT01681472
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012
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Purpose
The purpose of this study is to compare the concentration of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF in the tumor, in adjacent mucosa and in plasma in patients with colon cancer receiving two different does of Modufolin® and Levoleucovorin (Isovorin®) respectively (60 and 200 mg/m2).
| Condition | Intervention | Phase |
|---|---|---|
|
Colonic Neoplasms |
Drug: [6R] 5,10-methylenetetrahydrofolate Drug: Levoleucovorin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Single-blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® Compared to Levoleucovorin in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer |
Resource links provided by NLM:
Further study details as provided by Isofol Medical AB:
Primary Outcome Measures:
- Comparison of folate concentration in tumor tissue and adjacent mucosa between treatment arms. [ Time Frame: Sample taken Day 1 (Day of surgery). ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To explore if there is a difference in pharmacokinetic parameters of [6R] 5,10- methylene-THF, 5-formyl-THF, 5-methyl-THF and THF calculated from plasma concentration [ Time Frame: Samples taken on Screening visit, Day 1 and Day 2. ] [ Designated as safety issue: No ]
- To study safety in terms of adverse events and laboratory measurements; haematology, clinical chemistry and urinalysis. [ Time Frame: Screening visit until end of study, Day 5 ] [ Designated as safety issue: Yes ]
- To study gene expression in tumor and mucosa. [ Time Frame: Sample taken Day 1 (Day of Surgery) ] [ Designated as safety issue: No ]
- To study homocystein and serum folate levels. [ Time Frame: Samples taken at Screening visit, Day 2 and End of Study (Day 5) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2012 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Levoleucovorin 200 mg/m2 |
Drug: Levoleucovorin
i.v. bolus injection
Other Name: Isovorin®
|
| Active Comparator: Levoleucovorin 60 mg/m2 |
Drug: Levoleucovorin
i.v. bolus injection
Other Name: Isovorin®
|
| Experimental: 6R-MTHF 200 mg/m2 |
Drug: [6R] 5,10-methylenetetrahydrofolate
i.v. bolus injection
Other Names:
|
| Experimental: 6R-MTHF 60 mg/m2 |
Drug: [6R] 5,10-methylenetetrahydrofolate
i.v. bolus injection
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have operable colon cancer that is amenable to curative surgery.
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG).
- Patients without contra indications for undergoing surgery.
- For women: Must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test (within 7 days before enrolment) and must not be lactating.
- For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
- Patients must sign an informed consent document.
- Patient legally competent and able to communicate effectively with the study personnel as judged by the investigator.
- Patient likely to co-operate during the study.
- Patients must be 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/device that has not received regulatory approval for any indication at the time of study entry.
- Any intake of medication which could influence homocysteine, folate, and vitamin B12 status, within 30 days of surgery
- 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.
- 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.
- Presence of clinically relevant (i.e., detectable by physical examination) third-space fluid collection (e.g., ascites, pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry.
- Inability or unwillingness to be given Modufolin® or Levoleucovorin (Isovorin®).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681472
Contacts
| Contact: Anders G Rabbe | +46 70 764 65 00 | anders.rabbe@isofolmedical.com |
Locations
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Gothenburg, Sweden, 461 85 | |
| Contact: Hillevi Björkqvist, RN +46 31 343 66 57 hillevi.bjorkqvist@vgregion.se | |
| Principal Investigator: Kristoffer Derwinger, MD PhD | |
Sponsors and Collaborators
Isofol Medical AB
Investigators
| Principal Investigator: | Kristoffer Derwinger, MD PhD | Sahlgrenska University Hospital, Sweden |
More Information
No publications provided
| Responsible Party: | Isofol Medical AB |
| ClinicalTrials.gov Identifier: | NCT01681472 History of Changes |
| Other Study ID Numbers: | ISO-CC-002 |
| Study First Received: | September 5, 2012 |
| Last Updated: | September 7, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: Medical Products Agency Sweden: Swedish Data Inspection Board |
Keywords provided by Isofol Medical AB:
|
Colon cancer 5,10-methylenetetrahydrofolate Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Gastrointestinal Diseases Therapeutic Uses Pharmacokinetics Pharmacodynamics |
Additional relevant MeSH terms:
|
Neoplasms Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Levoleucovorin Leucovorin Tetrahydrofolates Antidotes Protective Agents Physiological Effects of Drugs Pharmacologic Actions Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013