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

PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

May 31, 2008

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

Trial Locations (9)

46202

Indiana University Cancer Center, Indianapolis

Quality Cancer Center (MCGOP), Indianapolis

46515

Elkhart Clinic, Elkhart

46527

Center for Cancer Care at Goshen Health System, Goshen

46601

Northern Indiana Cancer Research Consortium, South Bend

46815

Fort Wayne Oncology & Hematology, Inc, Fort Wayne

47150

Center for Cancer Care, Inc., P.C., New Albany

47303

Medical Consultants, P.C., Muncie

47804

AP&S Clinic, Terre Haute

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

collaborator

Walther Cancer Institute

OTHER

lead

Gabi Chiorean, MD

OTHER

NCT00216086 - Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer | Biotech Hunter | Biotech Hunter