A Phase II Trial of Preoperative Capecitabine Plus Irinotecan Followed by Combined Modality Capecitabine and Radiation for Locally Advanced Rectal Cancer: Hoosier Oncology Group GI03-53
18 Years
N/A
Both
Rectal Cancer
Trial Information
A Phase II Trial of Preoperative Capecitabine Plus Irinotecan Followed by Combined Modality Capecitabine and Radiation for Locally Advanced Rectal Cancer: Hoosier Oncology Group GI03-53
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 clearance of 30-50 mL/min or patients > 70years old, capecitabine
starting dose is 825 mg/m2 PO BID
Beginning at week 7 or following recovery from chemotherapy:
- 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
- Capecitabine 825* mg/m2 PO BID, 5 days/week, throughout XRT* For calculated creatinine
clearance of 30-50 mL/min or patients > 70years old, capecitabine starting dose is 650
mg/m2 PO BID
- Surgery within 8weeks following chemoradiotherapy
- Adjuvant Chemotherapy at investigator's discretion
ECOG performance status 0 or 1
Hematopoietic:·
- ANC count >1,500 mm3·
- Platelets > 100,000/mm3·
- Hemoglobin > 9g/dL
- Prothrombin time (PT)/INR or PTT < 1.25 times upper limit of normal;
Hepatic:·
- Bilirubin <1.5 times upper limit of normal
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) <2.5 times the upper limit
of normal
Renal:·
- Adequate renal function by calculated creatinine clearance > 30 mL/min (by Cockroft and
Gault)
Cardiovascular:·
- No congestive heart failure requiring therapy or NYHA class II or greater or active
angina or known myocardial infarction within 12 months prior to study
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
· To determine the pathological response rate of preoperative chemotherapy with capecitabine and irinotecan followed by combined modality chemoradiation with capecitabine in patients with locally advanced rectal cancer.
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Elena Gabriela Chiorean, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, LLC
Authority:
United States: Institutional Review Board
Study ID:
HOG GI03-53
NCT ID:
NCT00216086
Start Date:
January 2005
Completion Date:
May 2008
Related Keywords:
- Rectal Cancer
- Rectal Cancer
- Rectal Neoplasms
Name | Location |
|---|---|
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
| Northern Indiana Cancer Research Consortium | South Bend, Indiana |
| Elkhart Clinic | Elkhart, Indiana 46515 |
| Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
| Medical Consultants, P.C. | Muncie, Indiana 47303 |
| Center for Cancer Care, Inc., P.C. | New Albany, Indiana 47150 |
| AP&S Clinic | Terre Haute, Indiana 47804 |
| Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
