2] administered by prolonged intravenous infusion followed by leucovorin
rescue, has been widely used in the treatment of malignancies such as osteosarcoma, acute lymphoblastic leukemia, and lymphoma.
Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/ Leucovorin
in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators.
Hochster et al (32) have reported preliminary data utilizing oxaliplatin with weekly bolus 5-FU and low-dose leucovorin
every 3 of 4 weeks in an ongoing single arm study in newly diagnosed advanced colorectal cancer patients.
The MTD in the every-two-week FOLPI schedule of picoplatin when infused with 5-fluorouracil and leucovorin
has not yet been reached, and the trial is ongoing at a dose of 135 mg/m2.
These Phase 1 studies have explored different doses of picoplatin and different dosing schedules either in combination with docetaxel for prostate cancer or with 5-fluorouracil and leucovorin
for colorectal cancer.
Tumor-bearing mice treated with CoFactor, 5-FU and capecitabine had the greatest inhibition of tumor growth compared to the other drug regimens tested in this study, including capecitabine alone and a matched treatment regimen of leucovorin
(LV), 5-FU, and capecitabine.
The CoFactor Phase IIb clinical trial is designed to compare the safety and efficacy of CoFactor plus 5-FU to leucovorin
plus 5-FU in first line treatment of patients with metastatic colorectal carcinoma.
The combination regimen CapeOX, which is capecitabine (Xeloda, Roche) and oxaliplatin (Eloxatin, sanofi~aventis), was added as an alternate option to the combination of fluorouracil, leucovorin
and oxaliplatin (known as FOLFOX).
No other lots of Leucovorin
Calcium Injection are subject to this voluntary recall.
In the colorectal trial, AVASTIN([R]) and Leucovorin
are also administered.
The patients who received either oxaliplatin alone or 5-fluorouracil and leucovorin
infusions together in the multicenter, randomized, controlled study had very little improvement.
On July 3, 2012, Bedford Laboratories announced the nationwide voluntary recall of two lots of Leucovorin
Calcium Injection USP to the Hospital/User level.