Study Stopped
Funding withdrawn
Capecitabine + Irinotecan Followed by Combined Modality Capecitabine and Radiation in Locally Advanced Rectal Cancer
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
1 other identifier
interventional
22
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2005
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
June 6, 2016
CompletedJune 6, 2016
April 1, 2016
3 years
September 9, 2005
January 5, 2016
April 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological Complete Response (pCR) Rate
· 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. Pathological response was defined in the protocol as the proportion of complete (pCR) and non-complete pathological response (pNCR) among all evaluable patients.
36 months
Secondary Outcomes (3)
Local and Distant Disease Recurrence Rates
36 months
Rate of Clinical Response
36 months
Disease-Free Survival
36 months
Study Arms (1)
Investigational Treatment
EXPERIMENTAL* 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 \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid * EUS * Neoadjuvant Chemotherapy * Preoperative Radiation * Surgery * Adjuvant Chemotherapy (at discretion of treating physician)
Interventions
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
* Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
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
Adjuvant chemotherapy at investigator's discretion
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gabi Chiorean, MDlead
- Pfizercollaborator
- Roche Pharma AGcollaborator
- Walther Cancer Institutecollaborator
Study Sites (9)
Elkhart Clinic
Elkhart, Indiana, 46515, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202, United States
Medical Consultants, P.C.
Muncie, Indiana, 47303, United States
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
AP&S Clinic
Terre Haute, Indiana, 47804, United States
Related Publications (1)
Chiorean EG, Sanghani S, Schiel MA, Yu M, Burns M, Tong Y, Hinkle DT, Coleman N, Robb B, LeBlanc J, Clark R, Bufill J, Curie C, Loehrer PJ, Cardenes H. Phase II and gene expression analysis trial of neoadjuvant capecitabine plus irinotecan followed by capecitabine-based chemoradiotherapy for locally advanced rectal cancer: Hoosier Oncology Group GI03-53. Cancer Chemother Pharmacol. 2012 Jul;70(1):25-32. doi: 10.1007/s00280-012-1883-1. Epub 2012 May 18.
PMID: 22610353RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Hoosier Cancer Research Network, Inc.
Study Officials
- STUDY CHAIR
Elena Gabriela Chiorean, M.D.
Hoosier Oncology Group, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 22, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
June 6, 2016
Results First Posted
June 6, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share