Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
18 Years
74 Years
Both
Colorectal Cancer
Trial Information
Neoadjuvant Conformal Radiotherapy and Concomitant CPT-11 and EGFR Inhibition With Cetuximab in Patients With Rectal Cancer Phase I Study
OBJECTIVES:
Primary
- Determine the toxicity of irinotecan hydrochloride and cetuximab in patients with stage
III or IV rectal cancer undergoing conformal or intensity-modulated radiotherapy.
Secondary
- Determine the rate of pathologic response and histological degree of tumor regression
in patients treated with this regimen.
- Determine the complete resection rate (R0) in patients treated with this regimen.
- Determine the sphincter preservation rate in patients treated with this regimen.
- Determine the 30-day postoperative complication rate in patients treated with this
regimen.
- Determine the local and distant relapse rate and site of disease failure in patients
treated with this regimen.
- Estimate the predictive value of fludeoxyglucose F 18 positron emission tomography/CT
scan for treatment response compared to endoscopic ultrasonography (EUS), CT scan, and
MRI in patients treated with this regimen.
- Determine the late toxicity of this regimen in these patients.
- Determine the clinical (radiological) tumor response (i.e., MRI, CT scan, EUS) in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan hydrochloride.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, and 43 followed
by irinotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, and 29. Patients also
undergo conformal radiotherapy or intensity-modulated radiotherapy on days 1-5 for 5 weeks.
Patients undergo radical surgery 3-4 weeks after completion of neoadjuvant therapy.
Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for at least 5
years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- T3-4 and/or N+ (stage IIIB, IIIC, or IV disease)
- Liver or lung metastasis allowed
- No recurrent disease
PATIENT CHARACTERISTICS:
- WHO performance status 0 or 1
- Hematologic, liver, and renal function normal
- Considered fit for chemotherapy, radiotherapy, and surgery
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment
- No symptomatic heart disease or myocardial infarction during the past 6 months
- No chronic inflammatory bowel disease
- No malignant tumor during the past 5 years except for completely surgically resected
carcinoma of the cervix or squamous cell carcinoma of the skin
- No other concurrent malignant tumor
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy for rectal cancer
- No prior radiotherapy to the pelvis
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Radiological (clinical) tumor response before surgery
Safety Issue:
No
Principal Investigator
Michael Montemurro, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Universitaire Vaudois
Authority:
Unspecified
Study ID:
CDR0000512816
NCT ID:
NCT00392470
Start Date:
August 2006
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the rectum
- stage III rectal cancer
- stage IV rectal cancer
- Rectal Neoplasms
- Colorectal Neoplasms
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