Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01376453
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2011-06-16
Brief Title:
Pre-operative 5-Fluorouracil 5-FU and Sorafenib With External Radiation in Locally Advanced Rectal Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Study of Pre-operative Continuous 5-FU and Sorafenib With External Radiation Therapy in Locally Advanced Rectal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to find the maximum tolerable dose of sorafenib when administered along with another drug called 5-Fluorouracil 5-FU and to find out more about whether these drugs along with radiation can help people with rectal cancer when given before surgery 5-FU and radiation are both approved by the US Food and Drug Administration FDA for use in people with rectal cancer
The investigators will utilize a standard 3 3 phase I study design In the phase I part of the study the investigators will attempt dose escalation of sorafenib in combination with standard infusional 5-FU and external beam at standard doses Clinical staging should be done by endorectal ultrasound ERUS andor pelvic magnetic resonance imaging MRI for T and N stage chest and abdomen computed tomography CT for staging of metastatic disease undergo sigmoidoscopy andor colonoscopy done by crude odds ratios CORS biopsy is taken for diagnosis and extra is sent for tissue bank At the maximum tolerated dose MTD of sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile and efficacy
The investigators will utilize a standard 3 3 phase I study design In the phase I part of the study the investigators will attempt dose escalation of sorafenib in combination with standard infusional 5-FU and external beam at standard doses Clinical staging should be done by endorectal ultrasound ERUS andor pelvic magnetic resonance imaging MRI for T and N stage chest and abdomen computed tomography CT for staging of metastatic disease undergo sigmoidoscopy andor colonoscopy done by crude odds ratios CORS biopsy is taken for diagnosis and extra is sent for tissue bank At the maximum tolerated dose MTD of sorafenib we will expand the cohort to 6 more patients to further evaluate toxicity profile and efficacy
Detailed Description:
Participants study regimen will include 5 ½ weeks of radiation Radiation sessions will be daily Monday through Friday except for holidays 5-FU will be delivered at a dose of 225 mgm² daily through a catheter in a large vein continuously until the last day of radiation In addition sorafenib will be taken by mouth twice daily every day until the last day of radiation The dose of sorafenib participants may receive will be one of the following 200 mg every other day 200 mg daily 400 mg daily or 800 mg daily Following completion of this phase of the study participants will receive no study drug or radiation for one month At 4 to 5 weeks after stopping study drug and radiation participants will have another CT scan or MRI to assess their cancer About 6 to 8 weeks after the end of radiation participants will undergo surgery and every effort will be made to remove the tumor The surgery will occur just as it would if participants were not in the study except that a portion of their tumor obtained during surgery will be used for research biomarker testing as described in the consent form
Approximately 6 -10 weeks after participants surgery when they have adequately healed they may receive additional chemotherapy at their study doctors discretion
Approximately 6 -10 weeks after participants surgery when they have adequately healed they may receive additional chemotherapy at their study doctors discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IST 000575 | OTHER | Bayer Corporation | None |