Status:
COMPLETED
S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Mo...
Detailed Description
OBJECTIVES: * To assess the pathologic complete response rate for the combination of oxaliplatin, capecitabine, and cetuximab alone and concurrently with external beam radiotherapy for patients with ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-proven primary adenocarcinoma of the rectum
- Stage II or III disease
- The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination
- No recurrent disease
- Must have wild-type k-ras status
- Measurable and/or nonmeasurable disease
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Leukocyte count ≥ 3,000/mcL
- Granulocyte count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN
- Creatinine clearance \> 50 mL/min
- No prior severe reaction to a monoclonal antibody
- Willing to have specimens submitted
- No peripheral neuropathy ≥ grade 2
- No known existing uncontrolled coagulopathy
- No evidence of current high-grade obstruction
- At least 2 weeks since prior diverting procedure
- No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment
- No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency
- No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine
- No uncontrolled intercurrent illness
- No ongoing or active infection
- No symptomatic congestive heart failure or unstable angina pectoris
- No cardiac arrhythmia or myocardial infarction within the past 12 months
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years
- PRIOR CONCURRENT THERAPY:
- Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery)
- No prior chemotherapy, radiotherapy, or targeted therapy for this tumor
- More than 4 weeks since prior investigational agents
- No concurrent anti-retroviral therapy for HIV
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00686166
Start Date
February 1 2009
End Date
March 1 2018
Last Update
May 18 2018
Active Locations (130)
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1
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
2
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States, 85704
3
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
4
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024