Levoleucovorin Calcium

Therapeutic procedure, folic acid, Colorectal Carcinoma + 1 more
Treatment
6 FDA approvals
20 Active Studies for Levoleucovorin Calcium

What is Levoleucovorin Calcium

LevoleucovorinThe Generic name of this drug
Treatment SummaryLevoleucovorin is a medication used to counteract the toxic effects of folic acid antagonists, such as methotrexate. It is used to rescue patients from the side effects of high-dose methotrexate and also in combination with 5-fluorouracil to treat advanced colorectal cancer. Levoleucovorin is an active form of Folinic Acid and is converted in the body to methyl-tetrahydrofolate, a form of folic acid that is essential for the body's production of DNA and protein.
Fusilevis the brand name
image of different drug pills on a surface
Levoleucovorin Calcium Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Fusilev
Levoleucovorin
2008
30

Approved as Treatment by the FDA

Levoleucovorin, also called Fusilev, is approved by the FDA for 6 uses including Advanced Colorectal Cancer and Metastatic Colorectal Cancer (CRC) .
Advanced Colorectal Cancer
Used to treat Advanced Colorectal Cancer in combination with Fluorouracil
Metastatic Colorectal Cancer (CRC)
Used to treat Metastatic Colorectal Cancer (CRC) in combination with Fluorouracil
Colorectal Carcinoma
Used to treat Advanced Colorectal Cancer in combination with Fluorouracil
Therapeutic procedure
folic acid
Colorectal Cancer
Used to treat Metastatic Colorectal Cancer (CRC) in combination with Fluorouracil

Effectiveness

How Levoleucovorin Calcium Affects PatientsLevoleucovorin is taken up by cells and converted into 5-methyltetrahydrofolic acid. This active form of folate is then changed into a form called folylpolyglutamate, which is used in certain body processes.
How Levoleucovorin Calcium works in the bodyFolic acid is an important B vitamin that helps the body produce proteins and DNA. In order to do so, it must first be turned into cofactors by the enzyme dihydrofolate reductase (DHFR). When cancer patients take high doses of methotrexate, they are at risk of developing a deficiency in the cofactors DHF and THF. This can lead to the buildup of toxic substances, which can cause serious side effects. To avoid this, patients can take medications such as levoleucovorin and leucovorin, which are similar to THF and can replace it

When to interrupt dosage

The portion of Levoleucovorin Calcium is contingent upon the diagnosed affliction, like Colorectal Carcinoma, folic acid and Therapeutic procedure. The quantity of dosage is contingent upon the technique of delivery (e.g. Injection, solution or Injection, powder, lyophilized, for solution) featured in the table beneath.
Condition
Dosage
Administration
Therapeutic procedure
50.0 mg/mL, , 10.0 mg/mL, 50.0 mg, 17.5 mg/mL, 25.0 mg/mL, 175.0 mg/mL, 300.0 mg/mL, 5.0 mg/mL, 2.5 mg
, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection - Intravenous, Injection, Oral, Capsule, Capsule - Oral
folic acid
50.0 mg/mL, , 10.0 mg/mL, 50.0 mg, 17.5 mg/mL, 25.0 mg/mL, 175.0 mg/mL, 300.0 mg/mL, 5.0 mg/mL, 2.5 mg
, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection - Intravenous, Injection, Oral, Capsule, Capsule - Oral
Colorectal Carcinoma
50.0 mg/mL, , 10.0 mg/mL, 50.0 mg, 17.5 mg/mL, 25.0 mg/mL, 175.0 mg/mL, 300.0 mg/mL, 5.0 mg/mL, 2.5 mg
, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection - Intravenous, Injection, Oral, Capsule, Capsule - Oral
Colorectal Cancer
50.0 mg/mL, , 10.0 mg/mL, 50.0 mg, 17.5 mg/mL, 25.0 mg/mL, 175.0 mg/mL, 300.0 mg/mL, 5.0 mg/mL, 2.5 mg
, Intravenous, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous, Injection, solution, Injection, solution - Intravenous, Injection - Intravenous, Injection, Oral, Capsule, Capsule - Oral

Warnings

Levoleucovorin Calcium has two contraindications, thus it should not be employed when one has any of the conditions specified in the table below.Levoleucovorin Calcium Contraindications
Condition
Risk Level
Notes
folic acid
Do Not Combine
folic acid
Do Not Combine
There are 20 known major drug interactions with Levoleucovorin Calcium.
Common Levoleucovorin Calcium Drug Interactions
Drug Name
Risk Level
Description
5-fluorouridine
Major
The risk or severity of adverse effects can be increased when Levoleucovorin is combined with 5-fluorouridine.
Capecitabine
Major
The risk or severity of adverse effects can be increased when Levoleucovorin is combined with Capecitabine.
Doxifluridine
Major
The risk or severity of adverse effects can be increased when Levoleucovorin is combined with Doxifluridine.
Flucytosine
Major
The risk or severity of adverse effects can be increased when Levoleucovorin is combined with Flucytosine.
Fluorouracil
Major
The risk or severity of adverse effects can be increased when Levoleucovorin is combined with Fluorouracil.
Levoleucovorin Calcium Toxicity & Overdose RiskThe lethal dose of the drug when given intravenously to adult mice and rats has been found to be 575 mg/kg and 378 mg/kg, respectively.

Levoleucovorin Calcium Novel Uses: Which Conditions Have a Clinical Trial Featuring Levoleucovorin Calcium?

51 active studies are investigating the use of Levoleucovorin Calcium to treat Colorectal Carcinoma, Therapeutic procedures and Metastatic Colorectal Cancer.
Condition
Clinical Trials
Trial Phases
Therapeutic procedure
0 Actively Recruiting
Colorectal Cancer
46 Actively Recruiting
Phase 2, Phase 1, Phase 3, Not Applicable, Early Phase 1
Colorectal Carcinoma
0 Actively Recruiting
folic acid
0 Actively Recruiting

Levoleucovorin Calcium Reviews: What are patients saying about Levoleucovorin Calcium?

2Patient Review
1/15/2009
Levoleucovorin Calcium for High Blood Levels of Methotrexate
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Patient Q&A Section about levoleucovorin calcium

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Levoleucovorin used for?

"Levoleucovorin injection is used to prevent harmful effects of methotrexate in adults and children when methotrexate is used to treat osteosarcoma."

Answered by AI

What is the benefit of leucovorin calcium?

"This medication is used to treat or prevent certain blood cell disorders—such as thrombocytopenia, neutropenia, and anemia—that are caused by drugs such as folic acid antagonists (such as methotrexate, trimethoprim, and pyrimethamine)."

Answered by AI

Is Levoleucovorin the same as leucovorin?

"Levoleucovorin can be used in the same way as leucovorin to reduce the effects of fluorouracil."

Answered by AI

Is there calcium in leucovorin?

"There are 0.004 milliequivalents of calcium per milligram of leucovorin. The solution contains no bacteriostat or antimicrobial agents. Leucovorin Calcium for Injection is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 50 milligram, 100 milligram, 200 milligram, and 350 milligram vials."

Answered by AI

Clinical Trials for Levoleucovorin Calcium

Image of University of Kentucky in Lexington, United States.

Hepatic Artery Infusion Chemotherapy for Liver Cancer

18 - 99
All Sexes
Lexington, KY
The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are: * safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver) * help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital Participants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center. The main treatment on study will last about 3-4 months.
Phase 2
Waitlist Available
University of KentuckyMichael Cavnar, MD
Image of RJ Zuckerberg in Lake Success, United States.

Implantable Microdevice for Colorectal Cancer

18+
All Sexes
Lake Success, NY
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.
Phase < 1
Waitlist Available
RJ Zuckerberg
Image of RJ Zuckerberg in Lake Success, United States.

Nelitolimod for Colorectal Cancer

18+
All Sexes
Lake Success, NY
Nelitolimod is a classC toll-like receptor 9 (TLR9) agonist that binds to TLR9 receptors on myeloid-derived suppressor cells(MDSCs) and helps reshape the tumor microenvironment (TME) and promote antitumor immunity. Investigators hypothesize that Nelitolimod can induce antitumor immune response in CRLM when administered regionally to the liver via a TriNav Pressure Enabled Drug Delivery (PEDD) catheter without compromising surgical feasibility or patient safety. The study objective is to investigate the feasibility and safety of an innovative immunotherapeutic approach for patients with CRLM designed to overcome the immunosuppressive TME in CRLM. Investigators hypothesize that this investigational neoadjuvant treatment will be well tolerated and will not prevent patients from undergoing successful, safe CRLM liver resections. Investigators will assess the safety and feasibility of Nelitolimod given via TriNav PEDD in 10 patients with CRLM prior to liver resection. Patients will receive standard treatment with chemotherapy and then undergo placement of the PEDD catheter. Patients will then receive 3 doses of Nelitolimod before undergoing liver resection.
Phase < 1
Waitlist Available
RJ Zuckerberg
Image of START Midwest in Grand Rapids, United States.

BNT314 + BNT327 + Chemotherapy for Colorectal Cancer

18+
All Sexes
Grand Rapids, MI
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.
Phase 1 & 2
Recruiting
START MidwestBioNTech Responsible PersonBioNTech SE
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Image of University of Alabama at Birmingham in Birmingham, United States.

ProAgio for Colorectal Cancer

18+
All Sexes
Birmingham, AL
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with 5-fluorouracil, irinotecan (FOLFIRI) and bevacizumab for untreated advanced/metastatic CRC. The study will use an Accelerated titration BOIN design in Phase I to determine the recommended RP2D of ProAgio with FOLFIRI + bevacizumab. The trial will estimate the RP2D of ProAgio when combined with FOLFIRI + bevacizumab, starting from 2 dose levels lower than the estimated RP2D of ProAgio alone. Accelerated titration BOIN design will enroll patients with the 4 combination dose levels. Subjects will be selected based on following criteria: previously untreated advanced/metastatic CRC, ECOG performance status (0-1), and adequate organ functions. Subjects with recent surgeries, history of recent thromboembolic events or significant cardiovascular disease will be excluded. Once the MTD and RP2D of ProAgio with FOLFIRI have been identified, an expansion cohort of 12 subjects with advanced/metastatic CRC will begin. The purpose of the expansion cohort is to confirm the safety of the regimen and provide preliminary data on the activity of ProAgio + FOLFIRI + bevacizumab.
Phase 1
Recruiting
University of Alabama at BirminghamMidun Malla, MD
Image of Hope And Healing Cancer Services /ID# 271562 in Hinsdale, United States.

Telisotuzumab Adizutecan + Combination Therapy for Colorectal Cancer

18+
All Sexes
Hinsdale, IL
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Phase 2
Recruiting
Hope And Healing Cancer Services /ID# 271562 (+10 Sites)ABBVIE INC.AbbVie
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Image of Springfield Clinic /ID# 268666 in Springfield, United States.

ABBV-400 vs Standard Treatment for Colorectal Cancer

18+
All Sexes
Springfield, IL
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of telisotuzumab adizutecan. Each treatment arm in stage 2 receives the optimal dose of telisotuzumab adizutecan or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries. In stage 1, participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. In stage 2, participants will receive the optimal dose of IV infused telisotuzumab adizutecan or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Phase 3
Recruiting
Springfield Clinic /ID# 268666 (+26 Sites)ABBVIE INC.AbbVie
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