LEUCOVORIN SUMMARY
Leucovorin Calcium Tablets, USP
Leucovorin Calcium Tablets contain either 5 mg or 25 mg leucovorin as the calcium salt of N -[4-[[(2-amino-5-formyl-1, 4, 5, 6, 7, 8-hexahydro-4-oxo-6-pteridinyl)-methyl]amino]benzoyl]- L -glutamic acid.
Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.
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NEWS HIGHLIGHTS
Published Studies Related to Leucovorin
Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. [2009.07.01]
PURPOSE Three-year disease-free survival (DFS) was significantly improved in patients who had undergone resection with curative intent for stage II or III colon cancer who received bolus plus continuous-infusion fluorouracil plus leucovorin (LV5FU2) with the addition of oxaliplatin (FOLFOX4)... CONCLUSION Adding oxaliplatin to LV5FU2 significantly improved 5-year DFS and 6-year OS in the adjuvant treatment of stage II or III colon cancer and should be considered after surgery for patients with stage III disease.
Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. [2009.07.01]
PURPOSE The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer...
Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841. [2009.06.10]
PURPOSE: The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated... CONCLUSION: In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy.
Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: Cancer and Leukemia Group B Protocol 89803. [2009.04.10]
PURPOSE: Colon cancers exhibiting DNA mismatch repair (MMR) defects demonstrate distinct clinical and pathologic features, including better prognosis and reduced response to fluorouracil (FU) -based chemotherapy. This prospective study investigated adjuvant chemotherapy containing FU and irinotecan in patients with MMR deficient (MMR-D) colon cancers... CONCLUSION: Loss of tumor MMR function may predict improved outcome in patients treated with the IFL regimen as compared with those receiving FU/LV.
Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. [2009.02.10]
PURPOSE: This randomized study assessed whether the best overall response rate (ORR) of cetuximab combined with oxaliplatin, leucovorin, and fluorouracil (FOLFOX-4) was superior to that of FOLFOX-4 alone as first-line treatment for metastatic colorectal cancer. The influence of KRAS mutation status was investigated... CONCLUSION: KRAS mutational status was shown to be a highly predictive selection criterion in relation to the treatment decision regarding the addition of cetuximab to FOLFOX-4 for previously untreated patients with metastatic colorectal cancer.
Clinical Trials Related to Leucovorin
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck [Completed]
The purpose of this study is to determine the safety and maximum tolerated dose of the
combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily
assess whether the combination is effective in treating squamous cell carcinoma of the head
and neck.
High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. It is not yet known which chemotherapy regimen is more effective
for colon cancer.
PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without
leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in
treating patients who have undergone surgery for stage III colon cancer.
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination [Active, not recruiting]
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with
Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in
patients with metastatic colorectal adenocarcinoma.
Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as
levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors.
It is not yet known whether fluorouracil is more effective when given together with
leucovorin and/or levamisole after surgery in treating colon cancer.
PURPOSE: This randomized phase III trial is studying giving fluorouracil together with
leucovorin to see how well it works compared with giving fluorouracil together with
levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in
treating patients with Dukes' B or Dukes' C colon cancer.
Irinotecan, 5-Fluorouracil, and Leucovorin in Colorectal Carcinoma [Active, not recruiting]
This study will examine an investigational (experimental) agent Tetrathiomolybdate (TM)
combined with the chemotherapy drugs Irinotecan, 5-Fluorouracil (5-FU) and Leucovorin (LV).
This study will evaluate the safety and tolerability of the combination of these drugs when
they are used in the treatment of metastatic colorectal cancer.
This is a pilot clinical trial which will be studying the reactions of the patient's body and
tumor to the experimental treatment described above. The purpose of this study is to find
out what kind of side effects this experimental treatment causes and see how often these side
effects occur.
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