Status:
COMPLETED
Oxaliplatin, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of neoadjuvant oxaliplatin and capecitabine when combined with radiotherapy in patients with locally advanced adenocarcinoma of the rectum....
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- Tumor involving the distal 12 cm of the rectum (above the anal verge)
- Clinically staged by endoscopic ultrasound with one of the following criteria:
- T3-T4 disease
- Evidence of lymph node involvement, defined by the presence of ≥ 1 enlarged peri-rectal lymph node (≥ 1 cm in size)
- No known distant metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 to 75
- Performance status
- ECOG 0-1 OR
- Karnofsky 70-100%
- Life expectancy
- More than 1 year
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Other
- Able to receive oral medication
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No prior or concurrent significant neuropathy
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
- No ongoing or active infection
- No other concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception during and for 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent granulocyte-stimulating factors
- Chemotherapy
- No prior chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior pelvic radiotherapy
- Surgery
- Not specified
- Other
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00086931
Start Date
September 1 2003
End Date
May 1 2010
Last Update
March 8 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001