Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ECF · 1 trial · 1 indication
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs in participants with adenocarcinoma who have received at least one cycle of therapy.
| Arm | Type | Description |
|---|---|---|
| Arm A (ECF + cetuximab) | EXPERIMENTAL | Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab IV on days 1, 8 and 15. Patients receive epirubicin 50 mg/m\^2 IV after cetuximab on day 1 followed by cisplatin 60 mg/m\^2 IV over 60 minutes. On days 1-21, patients receive 5-fluorouracil 200 mg/m\^2/day continuous IV infusion. Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity. |
| Arm B (IC + cetuximab) | EXPERIMENTAL | Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1, 8 and 15. Patients receive cisplatin 30 mg/m\^2 IV over 30 minutes on days 1 and 8 after cetuximab. Patients also receive irinotecan 65 mg/m\^2 IV over 90 minutes on days 1 and 8 after receiving cisplatin.Treatment repeats every 21 days in the absence of disease progression and unacceptable toxicity. |
| ARM C (FOLFOX + cetuximab) | EXPERIMENTAL | Patients receive cetuximab 400 mg/m\^2 IV over 120 minutes on day 1 of the first cycle, then 250 mg/m\^2 IV over 60 minutes thereafter. Patients receive cetuximab on days 1 and 8. On Day 1, patients also receive oxaliplatin 85 mg/m\^2 IV over 120 minutes and leucovorin 400 mg/m\^2 IV over 120 minutes either concurrently with oxaliplatin via a separate infusion line or post oxaliplatin administration. Following leucovorin, patients will receive 5-fluorouracil 400 mg/m\^2 IV bolus injection, then 5-fluorouracil 2400 mg/m\^2 IV infusion over 46-48 hours. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| cetuximab | BIOLOGICAL | given IV |
| ECF | DRUG | epirubicin and 5-fluorouracil given IV |
| IC | DRUG | cisplatin and irinotecan given IV |
| FOLFOX | DRUG | oxaliplatin , leucovorin and 5-fluorouracil IV |
1. Metastatic disease of the esophagus or gastroesophageal junction 1. Histologic, cytologic or radiologic documentation of metastatic squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction. Radiologic, endoscopic, histologic or cytologic evidence of locally recu...
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ECF is an investigational small molecule being studied for the treatment of esophageal cancer. It is being evaluated in combination with chemotherapy and cetuximab for patients with metastatic esophageal cancer or gastroesophageal junction cancer. The drug is currently in Phase 2 clinical development.
ECF is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with esophageal cancer.
ECF is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial for the treatment of esophageal cancer.
ECF has been studied in one completed clinical trial, identified as NCT00381706. This Phase 2 trial enrolled 245 patients with metastatic esophageal cancer or gastroesophageal junction cancer. The trial evaluated combination chemotherapy and cetuximab with ECF in the United States.
ECF is a distinct drug candidate being developed by Bristol-Myers Squibb. It is being studied as part of a combination regimen that includes chemotherapy and cetuximab for the treatment of esophageal cancer. No alternative names for ECF have been disclosed.