Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019747
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2001-07-11
Brief Title:
Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of Oral Thalidomide as an Adjuvant Agent Following Metastasectomy in Patients With Recurrent Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB recommended closure of the protocol due to slow accrual
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 colorectal cancer by stopping blood flow to the tumor Giving thalidomide after surgery may kill any remaining tumor cells
PURPOSE This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer
PURPOSE This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo
Compare the time to recurrence in patients treated with these regimens
Determine whether serumplasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels as well as carcinoembryonic antigen CEA measurements aid in predicting time to recurrence in these patients
Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients
Determine whether patients receiving thalidomide develop measurable antiangiogenic activity
Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sitesincluding sites that were both resected and ablated Patients without evidence of residual disease are randomized to one of two treatment arms
Arm I Patients receive oral thalidomide once daily
Arm II Patients receive an oral placebo once daily Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for up to 3 years
PROJECTED ACCRUAL A total of 94 patients 47 per treatment arm will be accrued for this study within 3 years
Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo
Compare the time to recurrence in patients treated with these regimens
Determine whether serumplasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels as well as carcinoembryonic antigen CEA measurements aid in predicting time to recurrence in these patients
Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients
Determine whether patients receiving thalidomide develop measurable antiangiogenic activity
Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sitesincluding sites that were both resected and ablated Patients without evidence of residual disease are randomized to one of two treatment arms
Arm I Patients receive oral thalidomide once daily
Arm II Patients receive an oral placebo once daily Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for up to 3 years
PROJECTED ACCRUAL A total of 94 patients 47 per treatment arm will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000067098 | None | None | None |
| 99-C-0102 | None | None | None |