Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 5Fluorouracil
5-fluorouracil · 2 trials · 2 indications
September 27, 2013 is the date when data was last collected for the primary endpoint. Prior to this date, the manufacturing process for the BI-manufactured cetuximab was changed necessitating the need to switch participants to US commercial cetuximab. All other components of their treatment regimen remained unchanged and participants stayed in their original reporting group. Therefore, the number of participants in the BI-manufactured cetuximab treatment arm who had TEAEs includes TEAEs while participants received BI-manufactured and US-commercial cetuximab. Using September 27 cut-off, the analysis of TEAEs is confounded by the switch from BI-manufactured to US commercial cetuximab. TEAEs were defined as serious and other non-serious AEs that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-In group available in Reported Adverse Events module which is summary of serious and other non-serious AEs regardless of causality.
January 23, 2013 is the date when the first participant in the BI-manufactured cetuximab treatment arm switched to US commercial cetuximab due to changes in the manufacturing process for the BI-manufactured cetuximab necessitating the need to switch participants to US commercial cetuximab. Each participant who switched treatments received at least 2 cycles of BI-manufactured cetuximab before switching. All other components of their treatment regimen remained unchanged. The number of participants who had TEAEs during combination therapy is reported. Using January 23 cut-off, data is un-confounded by lack of BI-manufactured cetuximab. TEAEs were defined as serious and other non-serious adverse events (AEs) that occurred or worsened after study treatment (regardless of causality). TEAE information for Safety Lead-in group available in Reported Adverse Event module which is summary of serious and other non-serious AEs regardless of causality.
| Arm | Type | Description |
|---|---|---|
| Cetuximab+FOLFOX4 | EXPERIMENTAL | * Day 1 - cetuximab loading dose of 400 mg/m2 IV, infused over 2 hours; oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion * Day 8 - cetuximab maintenance dose of 250 mg/m2 IV infused over 60 minutes |
| FOLFOX4. | ACTIVE_COMPARATOR | * Day 1 - oxaliplatin (85 mg/m2) simultaneously with leucovorin (200 mg/m2), followed by 5-FU 400 mg/m2 IV bolus followed by 5-FU 600 mg/m2 as a 22-hour continuous infusion. * Day 2 - leucovorin 200 mg/m2 followed by 5-FU 400 mg/m2 IV bolus followed by another dose of 5-FU 600 mg/m2 as a 22-hour continuous infusion. |
| Safety Lead-In (cetuximab manufactured by ImClone) | EXPERIMENTAL | Cycle 1: Week 1 - Cetuximab 400 milligrams per square meter (mg/m\^2) on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin area under the curve (AUC) 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met. |
| Cetuximab manufactured by ImClone | EXPERIMENTAL | Cycle 1: Week 1 - Cetuximab 400 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met. |
| Cetuximab manufactured by Boehringer Ingelheim | EXPERIMENTAL | Cycle 1: Week 1 - Cetuximab 400 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 Cycle 2-6: Week 1 - Cetuximab 250 mg/m\^2 on Day 1; Cisplatin 100 mg/m\^2 on Day 1 or carboplatin AUC 5 on Day 1; 5-FU 1000 mg/m\^2 on Days 1-4 Week 2 - Cetuximab 250 mg/m\^2 on Day 1 Week 3 - Cetuximab 250 mg/m\^2 on Day 1 After 6 cycles, participants may then receive weekly cetuximab monotherapy 250 mg/m\^2 until progression of disease, unacceptable toxicity, or another withdrawal criteria is met. |
| Name | Type | Description |
|---|---|---|
| cetuximab | BIOLOGICAL | 400 mg/m2 IV |
| oxaliplatin | DRUG | 85 mg/m2 IV |
| leucovorin | DRUG | 200 mg/m2 IV |
| 5-fluorouracil | DRUG | 400 mg/m2 IV |
| Cisplatin | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
Inclusion Criteria: * Documented colorectal cancer which is EGFR-positive and is metastatic. * Prior irinotecan, alone or in combination, as first-line treatment of metastatic disease. Exclusion Criteria: * A serious uncontrolled medical disorder that, in the opinion of the Investigator, would im...
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5-Fluorouracil is a small molecule oncology drug being studied for use in solid tumors, colorectal cancer, and head and neck cancer. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being developed by Eli Lilly and Company.
Eli Lilly and Company (NYSE: LLY) is the developer of 5-Fluorouracil. The company is conducting clinical trials of the drug in oncology indications including colorectal cancer, head and neck cancer, and solid tumors.
5-Fluorouracil is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed in colorectal cancer, head and neck cancer, and solid tumors.
5-Fluorouracil has been studied in three completed clinical trials. NCT00061815 was a Phase 3 study in colorectal cancer with 102 participants. NCT01081041 was a Phase 2 study in head and neck cancer with 187 participants. NCT01099358 was a Phase 2 study in advanced solid tumors with 47 participants.
Yes, 5-Fluorouracil is also known as 5Fluorouracil and 5-fluorouracil. These names refer to the same drug being developed by Eli Lilly and Company for oncology indications.