Approval Probability
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Adjusted LOA
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Modified Bolus 5-FU/LV with Irinotecan · 1 trial · 1 indication
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
| Arm | Type | Description |
|---|---|---|
| Modified Bolus 5-FU/LV with Irinotecan | EXPERIMENTAL | - |
| FOLFIRI + bevacizumab | EXPERIMENTAL | - |
| miFL + bevacizumab | EXPERIMENTAL | - |
| Infusional 5-FU/LV with Irinotecan | EXPERIMENTAL | - |
| Oral Capecitabine with Irinotecan | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Modified Bolus 5-FU/LV with Irinotecan | DRUG | Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID \[two times a day\] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment). |
| FOLFIRI + bevacizumab | DRUG | Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID \[two times a day\] oral Every 2 weeks |
| miFL + bevacizumab | DRUG | Day 1 Bevacizumab 7.5mg/kg IV \*over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID \[two times a day\] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID \[two times a day\] continues daily without interruption Every 3 weeks |
| Infusional 5-FU/LV with Irinotecan | DRUG | Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID \[two times a day\](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment). |
| Oral Capecitabine with Irinotecan | DRUG | Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID \[two times a day\] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment). |
Inclusion Criteria: * Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease) * Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have be...
Modified Bolus 5-FU/LV with Irinotecan is an investigational combination regimen being studied for the treatment of colorectal neoplasms, which are tumors of the colon or rectum. It combines the chemotherapy drugs fluorouracil (5-FU), leucovorin (LV), and irinotecan in a modified bolus administration schedule.
Modified Bolus 5-FU/LV with Irinotecan is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The regimen is a combination of established chemotherapy agents rather than a single novel molecular entity.
Modified Bolus 5-FU/LV with Irinotecan is in Phase 3 clinical development. It is an investigational regimen and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the regimen remains under clinical investigation for colorectal neoplasms.
Modified Bolus 5-FU/LV with Irinotecan was studied in one completed Phase 3 clinical trial, registered as NCT00101686. The trial, titled 'Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine,' enrolled 547 participants with colorectal neoplasms across the United States, Australia, Canada, and New Zealand.
Modified Bolus 5-FU/LV with Irinotecan is a regimen that combines fluorouracil, leucovorin, and irinotecan, similar in composition to the FOLFIRI regimen. However, the specific administration schedule and dosing details of this modified bolus version may differ from standard FOLFIRI protocols.