Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081224
Status:
TERMINATED
Last Update Posted:
2016-12-15
First Post:
2004-04-07
Brief Title:
Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma Cancer of the Rectum
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial Of Celecoxib Celebrex And Capecitabine Xeloda Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum
Status:
TERMINATED
Status Verified Date:
2016-12
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 Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma cancer of the rectum
PURPOSE This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma cancer of the rectum
Detailed Description:
OBJECTIVES
Primary
Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation
Secondary
Determine the safety and tolerability of this regimen in these patients
Determine the rectal function of patients treated with this regimen
Determine the time to recurrence or progression and survival time of patients treated with this regimen
Correlate cellular and molecular markers in pretreatment tumor samples with response in patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemoradiotherapy Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5 Patients undergo pelvic radiotherapy once daily on days 1-5 Courses repeat weekly for 55 weeks
Surgery Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy
Adjuvant chemotherapy Patients with a curative resection receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for up to 4 courses
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 4 years
Primary
Determine the pathological complete response rate in patients with stage II or III adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in combination with pelvic irradiation
Secondary
Determine the safety and tolerability of this regimen in these patients
Determine the rectal function of patients treated with this regimen
Determine the time to recurrence or progression and survival time of patients treated with this regimen
Correlate cellular and molecular markers in pretreatment tumor samples with response in patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemoradiotherapy Patients receive oral celecoxib twice daily on days 1-7 and oral capecitabine twice daily on days 1-5 Patients undergo pelvic radiotherapy once daily on days 1-5 Courses repeat weekly for 55 weeks
Surgery Patients undergo surgery 4-6 weeks after completion of neoadjuvant chemoradiotherapy
Adjuvant chemotherapy Patients with a curative resection receive oral capecitabine twice daily on days 1-14 Treatment repeats every 21 days for up to 4 courses
Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 4 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 |
|---|---|---|---|
| NCI-2012-02582 | REGISTRY | None | None |
| CDR0000360666 | REGISTRY | PDQ Physician Data Query | None |