Status:
COMPLETED
Bortezomib, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Rectal Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouraci...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of bortezomib when administered in combination with fluorouracil and external beam radiotherapy as preoperative or palliative treatment in ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy confirmed diagnosis of adenocarcinoma of the rectum meeting 1 of the following clinical staging criteria:
- T3-T4, N0, M0 (stage II disease)
- T4 disease defined as tumor fixed on examination or involving adjacent pelvic structures, such as the sidewall, bladder, uterus, prostate, or small bowel by ultrasound or CT scan
- Any T, N1-2, M0 (stage III disease)
- Any T, any N, M1 (stage IV disease)
- Recurrent disease (any prior stage)
- Candidate for local palliative therapy or curative resection of metastatic disease
- Previously treated CNS disease allowed provided it is stable for \> 3 months
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 3 months
- Adequate nutrition
- WBC ≥ 4,000/mm³
- ANC \> 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min
- Bilirubin ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious medical or psychiatric illness that would limit study compliance or limit survival to \< 2 years
- No history of refractory congestive heart failure or cardiomyopathy
- No active coronary artery disease, myocardial infarction within the past 3 months, or cerebrovascular accident within the past 3 months
- No peripheral neuropathy ≥ grade 2
- No hypersensitivity to bortezomib, boron, or mannitol
- PRIOR CONCURRENT THERAPY:
- More than 1 week since prior major surgery
- More than 28 days since prior investigational agents
- Prior chemotherapy allowed
- No prior pelvic radiotherapy (for treatment of any pelvic malignancy)
- No concurrent herbal medication (excluding vitamin and mineral supplements)
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00280176
Start Date
April 1 2003
End Date
September 1 2010
Last Update
February 14 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838