Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze - Full Text View

Sponsor:	Protherics
Information provided by:	Protherics
ClinicalTrials.gov Identifier:	NCT00634504

Purpose

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.

Condition	Intervention	Phase
Osteosarcoma Leukemia Lymphoma	Drug: glucarpidase, high-dose methotrexate, leucovorin Drug: high-dose methotrexate, leucovorin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label Study to Assess the Pharmacokinetics of Leucovorin in Patients Receiving High Dose Methotrexate, With or Without Voraxaze Treatment

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Lymphoma

Drug Information available for: Leucovorin Methotrexate Citrovorum factor Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by Protherics:

Primary Outcome Measures:

Pharmacokinetics (PK) of leucovorin [ Time Frame: Up to 3 hours after leucovorin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics (PK) of methotrexate [ Time Frame: Up to 3 hours after leucovorin ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	May 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A High-dose methotrexate, leucovorin, and Voraxaze	Drug: glucarpidase, high-dose methotrexate, leucovorin single intravenous dose Other Names: Voraxaze, carboxypeptidase G2, CPG2 HDMTX, LV
Active Comparator: B High-dose methotrexate and leucovorin without Voraxaze	Drug: high-dose methotrexate, leucovorin standard of care, leucovorin every 6 hours Other Name: HDMTX, LV

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
Require intravenous leucovorin

Exclusion Criteria:

Arm A only: allergic reactions to lactose
Arm A only: hereditary fructose or galactose intolerance
Arm B only: delayed elimination of MTX

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634504

Show 25 Study Locations

Sponsors and Collaborators

Protherics

Investigators

Study Chair:	Andrew Saunders, MD
Study Director:	Suzanne Kincaid, CCRA	Protherics

More Information

No publications provided

Responsible Party:	Suzanne Kincaid, Clinical Project Manager, Protherics
ClinicalTrials.gov Identifier:	NCT00634504 History of Changes
Other Study ID Numbers:	PR001-CLN-pro017
Study First Received:	March 6, 2008
Last Updated:	January 19, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Protherics:

high dose methotrexate
Voraxaze
leucovorin
delayed elimination

methotrexate toxicity
rescue
renal insufficiency

Additional relevant MeSH terms:

Leukemia
Lymphoma
Osteosarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Leucovorin
Levoleucovorin

Methotrexate
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012