Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310076
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2006-03-29
Brief Title:
Thalidomide in Treating Patients Who Have Undergone Surgery and Chemotherapy for Cancer That Has Spread Throughout the Abdomen Due to Colorectal Cancer or Appendix Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Trial of Adjuvant Thalidomide Following Cytoreductive Surgery and Intraperitoneal Hyperthermic Chemotherapy for Peritoneal Carcinomatosis or Adenomucinosis From ColorectalAppendiceal Cancer
Status:
COMPLETED
Status Verified Date:
2018-07
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:
RATIONALE Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor Giving thalidomide after surgery and chemotherapy may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer
PURPOSE This phase II trial is studying how well thalidomide works in treating patients who have undergone surgery and received chemotherapy directly into the abdomen by hyperthermic perfusion for cancer that has spread throughout the abdomen due to colorectal cancer or appendix cancer
Detailed Description:
OBJECTIVES
Primary
Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant thalidomide
Secondary
Estimate progression-free survival probability of patients treated with this regimen
Obtain toxicity data for patients receiving long-term oral thalidomide therapy
OUTLINE Patients receive oral thalidomide once daily on days 1-28 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 12 months
Primary
Determine time to progression from surgery in patients who have undergone cytoreductive surgery and intraperitoneal hyperthermic chemotherapy for peritoneal carcinomatosis or adenomucinosis secondary to colorectal or appendiceal cancer treated with adjuvant thalidomide
Secondary
Estimate progression-free survival probability of patients treated with this regimen
Obtain toxicity data for patients receiving long-term oral thalidomide therapy
OUTLINE Patients receive oral thalidomide once daily on days 1-28 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CCCWFU-59202 | None | None | None |
| CCCWFU-BG02-406 | None | None | None |
| CELGENE-CCCWFU-59202 | None | None | None |