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

Part of paid clinical trials in Elkhart, Indiana.

Sponsor
Gabi Chiorean, MD
Study ID
NCT00216086
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    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 — DRUG
    Irinotecan 200 mg/m2 IV, day 1
  • EUS — PROCEDURE
    biopsy per EUS
  • Neoadjuvant Chemotherapy — DRUG
    * Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles
  • Preoperative Radiation — PROCEDURE
    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
  • Surgery — PROCEDURE
    Surgery within 8 weeks following chemoradiotherapy
  • Adjuvant Chemotherapy — PROCEDURE
    Adjuvant chemotherapy at investigator's discretion

Study Details

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.

Key Dates

Start date
May 31, 2005
Status verified
Apr 2016
Primary completion
May 31, 2008
Completion
May 31, 2008

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Treatment
    * 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)

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: 36 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Elkhart ClinicElkhartIndiana46515-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Center for Cancer Care at Goshen Health SystemGoshenIndiana46527-
Indiana University Cancer CenterIndianapolisIndiana46202-
Quality Cancer Center (MCGOP)IndianapolisIndiana46202-
Medical Consultants, P.C.MuncieIndiana47303-
Center for Cancer Care, Inc., P.C.New AlbanyIndiana47150-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
AP&S ClinicTerre HauteIndiana47804-

Find similar trials in Elkhart, IN

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Elkhart Clinic· Elkhart, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, INCenter for Cancer Care at Goshen Health System· Goshen, INIndiana University Cancer Center· Indianapolis, INQuality Cancer Center (MCGOP)· Indianapolis, INMedical Consultants, P.C.· Muncie, IN

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