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Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer Clinical research trials and Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer. Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer  Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
For Condition: stage 2 rectal cancer,adenocarcinoma of the rectum,stage 3 rectal cancer
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of bevacizumab combined with fluorouracil and external-beam radiation therapy in treating patients who have stage II or stage III rectal cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of neoadjuvant bevacizumab when administered with fluorouracil and external beam radiotherapy in patients with stage II or III rectal cancer. - Determine the progression-free survival, local control, and overall survival of patients treated with this regimen. - Determine the pathological response rate of patients treated with this regimen. - Determine, preliminarily, the changes in the angiogenic profile of this disease in these patients induced by this regimen. OUTLINE: This is a multicenter, dose-escalation study of bevacizumab. Patients receive bevacizumab IV over 30-90 minutes on day 1 (courses 1-4). Beginning with course 2, patients also receive fluorouracil IV continuously on days 1-14 and undergo external beam radiotherapy on days 1-5 and 8-12. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo surgery 7 weeks after completion of chemoradiotherapy. Cohorts of 6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at the MTD. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: Approximately 4-32 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum - Begins within 15 cm of the anal verge by sigmoidoscopy and/or colonoscopy - Stage II or III disease - Clinical T3 or T4 tumors, as indicated by the following: - Tethered or fixed tumor on physical exam - cT3, cT4, or N+ disease by endorectal ultrasound or surface coil MRI - No evidence of metastatic disease by physical examination, chest radiograph, and abdominal/pelvic CT scan - No primary brain tumor or brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy - More than 2 years Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding diathesis or coagulopathy Hepatic - Bilirubin normal - AST/ALT less than 2.5 times upper limit of normal - INR less than 1.5* NOTE: *For patients receiving warfarin Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min - No proteinuria OR - Protein less than 500 mg/24-hour collection Cardiovascular - No history of stroke - No history of deep vein thrombosis - No clinically significant cardiovascular disease, including: - Uncontrolled hypertension - Myocardial infarction - Unstable angina pectoris - No New York Heart Association grade II-IV congestive heart failure - No serious cardiac arrhythmia requiring medication - No grade II or greater peripheral vascular disease within the past year Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV or HIV risk factors - HIV testing not required - No other concurrent active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix - Completed therapy and considered to be at less than 30% risk of relapse at least 5 years after all therapy - No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents - No serious non-healing wound, ulcer, or bone fracture - No evidence of CNS disease (e.g., seizures not controlled with standard medical therapy) - No significant traumatic injury within the past 28 days - No active infection requiring parenteral antibiotics - No other concurrent uncontrolled illness - No concurrent psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No prior bevacizumab Chemotherapy - No prior fluorouracil-based therapy for any malignancy - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy except the following: - Steroids for adrenal failure or allergic reactions - Hormones for non-disease-related conditions (e.g., insulin for diabetes) - Intermittent dexamethasone as an antiemetic Radiotherapy - No prior pelvic radiotherapy Surgery - More than 28 days since prior major surgery or open biopsy - More than 7 days since prior biopsy (except rectal cancer) - More than 7 days since prior placement of vascular access device - No other concurrent planned major surgery Other - More than 10 days since prior full-dose oral or parenteral anticoagulants or thrombolytic agents (except to maintain patency of preexisting, permanent indwelling IV catheters) - No prior treatment for this malignancy - No concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents (except to maintain patency of preexisting, permanent indwelling IV catheters) - No concurrent chronic aspirin use (more than 325 mg/day) - No concurrent nonsteroidal anti-inflammatory medications (of the kind known to inhibit platelet function at doses used to treat chronic inflammatory diseases) - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyClark, Study Chair, Massachusetts General Hospital
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Christopher Willett 617-724-1548
Additional Information:
Study ID Numbers: CDR0000258532; DFCI-02025,NCI-5642
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052559
Other Stage 3 Rectal Cancer Studies:
1. Chemotherapy, Radiation Therapy, and Surgery With or Without Epoetin alfa in Treating Patients With Resectable Rectal Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Induction Chemotherapy Followed By Chemoradiotherapy in Treating Patients With Locally Advanced Adenocarcinoma of the Rectum
4. Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
5. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Related Studies:
Other stage 3 rectal cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Bevacizumab, Fluorouracil, and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
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