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

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 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.

Conditions

• Rectal Cancer

Interventions

DRUG

Capecitabine

Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid

DRUG

Irinotecan

Irinotecan 200 mg/m2 IV, day 1

PROCEDURE

EUS

biopsy per EUS

DRUG

Neoadjuvant Chemotherapy

* Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles

PROCEDURE

Preoperative Radiation

Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4

PROCEDURE

Surgery

Surgery within 8 weeks following chemoradiotherapy

PROCEDURE

Adjuvant Chemotherapy

Adjuvant chemotherapy at investigator's discretion

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• Roche Pharma AG

  collaborator INDUSTRY

• Walther Cancer Institute

  collaborator OTHER

• Gabi Chiorean, MD

  lead OTHER

Principal Investigators

• Elena Gabriela Chiorean, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-05-31

Primary Completion

2008-05-31

Completion

2008-05-31

Countries

• United States

Study Locations