Status:
TERMINATED
Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer
Lead Sponsor:
Gabi Chiorean, MD
Collaborating Sponsors:
Pfizer
Roche Pharma AG
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Preoperative induction chemotherapy has been successfully used in a variety of malignancies and provides several advantages over postoperative therapy. Combination of 5-FU/Leucovorin/CPT-11 has demons...
Detailed Description
OUTLINE: This is a multi-center study. Biopsy per EUS * Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000\* mg/m2 PO BID day 1-14 Repeat every three weeks for two cycles\* For calculated creatinine...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the rectum \< 15 cm from the anal verge without evidence of distant metastasis·
- Measurable disease. ·
- Either mobile cancers (with clinical stage T3 or T4 by endorectal ultrasound) or fixed cancer (defined as clinical T4 for this study) on palpation. ·
- Malignant disease may not extend to the anal canal (across the dentate line)
Exclusion
- No prior chemotherapy or radiation therapy to the pelvis.
- Patients with clinical stage T 1-2, N0 rectal cancer who are candidates for primary resection are not eligible·
- No synchronous colonic cancer unless the synchronous tumor is Tis or T1 and has been completely resected·
- Patients must not be taking warfarin·
- No prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-Fluorouracil or known DPD deficiency.·
- No known existing uncontrolled coagulopathy·
- Negative pregnancy test·
- No current breastfeeding·
- No serious concomitant systemic disorders incompatible with the study· No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin, carcinoma in-situ of the cervix, or any other cancer for which the patient has been disease-free for \< 5 years.·
- Patients must not be treated with any of the following while on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol.
- Patients on dilantin must have regular monitoring of dilantin levels.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00216086
Start Date
May 1 2005
End Date
May 1 2008
Last Update
June 6 2016
Active Locations (9)
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1
Elkhart Clinic
Elkhart, Indiana, United States, 46515
2
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
3
Center for Cancer Care at Goshen Health System
Goshen, Indiana, United States, 46527
4
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202