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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Rectal Cancer

Thank you

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 CenterIndianapolis, Indiana  46202-5265
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Elkhart ClinicElkhart, 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 ClinicTerre Haute, Indiana  47804
Fort Wayne Oncology & Hematology, IncFort Wayne, Indiana  46815