Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer

Stopped early · Phase 2

Conditions studied: Rectal Cancer

In brief

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 demonstrated significantly better response rate than 5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has emerged as a potentially more effective, safe and convenient treatment option for metastatic colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with radiation. Recent data has shown that preoperative radiation appears to be significantly more effective in increasing resectability rates. This trial will investigate the activity of capecitabine and CPT-11 combination in the preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal cancer to improve response and decrease local recurrence. We will also study whether TS, TP, DPD and carboxyesterase expressions correlate with the objective response rate with this chemotherapy and chemoradiation regimen.

Key facts

Study ID

NCT00216086

Run by

Gabi Chiorean, MD

People needed

22

Starts

2005-05-01

Expected to finish

2008-05-01

Last updated by the study team

2016-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Elkhart Clinic — Elkhart, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Center for Cancer Care at Goshen Health System — Goshen, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Quality Cancer Center (MCGOP) — Indianapolis, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Center for Cancer Care, Inc., P.C. — New Albany, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• AP&S Clinic — Terre Haute, Indiana, United States

Full record on ClinicalTrials.gov

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