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Fluoropyrimidine-based Chemotherapy · 1 trial · 1 indication
A serious adverse event was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Specific adverse events (Spec AEs) included the following: hypertension, bleeding/hemorrhage, proteinuria, wound healing complications, thrombosis/thrombus/embolism (t/t/e), thrombosis/thrombus/embolism - vascular access, gastrointestinal perforation, and infusion (injection) site reaction.
| Arm | Type | Description |
|---|---|---|
| Bevacizumab | EXPERIMENTAL | Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. |
| Fluoropyrimidine-based Chemotherapy | DRUG | Fluoropyrimidine-based chemotherapy administered according to standard of care. |
Inclusion Criteria: * Previously untreated metastatic colon or rectal cancer; * Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment. Exclusion Criteria: * Prior chemotherapy for metastatic colon or rectal cancer; * Planned radiotherapy for underlying disease; * centra...
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Fluoropyrimidine-based Chemotherapy is used for the treatment of Colorectal Cancer, specifically in combination with bevacizumab (Avastin) for participants with metastatic cancer of the colon or rectum. It is a small molecule modality being studied in the oncology therapeutic area.
Fluoropyrimidine-based Chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this chemotherapy regimen for colorectal cancer.
Fluoropyrimidine-based Chemotherapy is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with colorectal cancer.
Fluoropyrimidine-based Chemotherapy is associated with one completed Phase 3 clinical trial, NCT01169558, titled 'A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.' The trial enrolled 168 participants in Brazil and included adults aged 18 years and older.
No, Fluoropyrimidine-based Chemotherapy is not the same as bevacizumab. It is a chemotherapy regimen that is studied in combination with bevacizumab (Avastin) for the treatment of metastatic colorectal cancer. The two are distinct drugs used together in the clinical trial.