Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00215956
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2005-09-19
Brief Title:
A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-01
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:
This is an open-label single center phase I study designed to determine the MTD or oral topotecan as a radiosensitizing agent in the treatment of rectal cancer patients Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation 45GY over five weeks
Detailed Description:
This is an open-label single center phase I study designed to determine the MTD or oral topotecan as a radiosensitizing agent in the treatment of rectal cancer patients Sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation 45GY over five weeks The starting dose of oral topotecan is 025mgm2 to be concomitantly administered with radiation 45Gy x 5 days every week unless the radiation is interrupted for HolidaysWeekends or toxicity requiring treatment delays occurs
A total of 25 doses is planned Doses will be escalated in 015 mgm2 increments thereafter in subsequent cohorts Topotecan will be administered immediately before daily radiation
All patients will undergo a rectal biopsy before treatment begins and during treatment Tissue will be submitted to H Lee Moffitt Cancer Center for tumor marker assays Tissue from the excised tumor at the time of surgery will also be sent for the same studies Between day 10 and 14 of treatment colonoscopysigmoidoscopy is mandatory to ensure having a quantitative estimate of the tumor shrinkage and to obtain a repeat rectal biopsy All patients will undergo radiation therapy concurrently with oral topotecan Patients will receive 180 cGY per fraction to a total dose of 4500cGyconventional fractionation to the pelvis using a 3 or 4 filed technique and high energy photons Standardized fields for rectal cancer will be used to include the true pelvis mid sacrum to at least 2-3 centimeters below the inferior aspect of the tumor volume
Patients will undergo surgery-either a low anterior resection abdominoperineal resection or local excision All patients will be offered postoperative adjuvant chemotherapy consisting of 5-Fluorouracil F-FU 350 mgm2day iv for 5 days administered every 28 days times four cycles Immediately prior to the administration of 5-FU leucovorin will be administered at a dose of 20 mgm2day iv push daily for 5 days every 28 days times four cycles
A total of 25 doses is planned Doses will be escalated in 015 mgm2 increments thereafter in subsequent cohorts Topotecan will be administered immediately before daily radiation
All patients will undergo a rectal biopsy before treatment begins and during treatment Tissue will be submitted to H Lee Moffitt Cancer Center for tumor marker assays Tissue from the excised tumor at the time of surgery will also be sent for the same studies Between day 10 and 14 of treatment colonoscopysigmoidoscopy is mandatory to ensure having a quantitative estimate of the tumor shrinkage and to obtain a repeat rectal biopsy All patients will undergo radiation therapy concurrently with oral topotecan Patients will receive 180 cGY per fraction to a total dose of 4500cGyconventional fractionation to the pelvis using a 3 or 4 filed technique and high energy photons Standardized fields for rectal cancer will be used to include the true pelvis mid sacrum to at least 2-3 centimeters below the inferior aspect of the tumor volume
Patients will undergo surgery-either a low anterior resection abdominoperineal resection or local excision All patients will be offered postoperative adjuvant chemotherapy consisting of 5-Fluorouracil F-FU 350 mgm2day iv for 5 days administered every 28 days times four cycles Immediately prior to the administration of 5-FU leucovorin will be administered at a dose of 20 mgm2day iv push daily for 5 days every 28 days times four cycles
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 |
|---|---|---|---|
| USFIRB5881 | None | None | None |