Status:
TERMINATED
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Se...
Detailed Description
OBJECTIVES: Primary * To determine the complete pathological response rate of the combination of capecitabine, oxaliplatin, selenomethionine, and radiotherapy in patients with stage II or III rectal...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed rectal adenocarcinoma that is involving the distal 12 cm of the rectum (above the anal verge)
- Staged within 8 weeks prior to initiation of study by endoscopic ultrasound OR MRI or CT scan if endorectal ultrasound is non-conclusive or non-tolerable
- T3-T4 tumor or evidence of lymph node involvement defined by the presence of at least 1 enlarged peri-rectal lymph node
- No evidence of distant or known metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy \> 1 year
- Leukocytes ≥ 3,000/µL
- Absolute neutrophil count ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Total bilirubin ≤ upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN
- Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min
- Able to receive oral medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent or previous malignancies unless disease free for \> 5 years (excluding nonmelanoma skin cancer)
- No neuropathy ≥ grade 2
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or selenomethionine
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the pelvis
- No prior chemotherapy
- No other concurrent investigational or anticancer agents or therapies
- No concurrent vitamin B6 supplementation (except as part of a standard, multivitamin supplement)
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00625183
Start Date
March 1 2008
End Date
December 1 2009
Last Update
November 17 2017
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001