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Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical research trials and Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer. Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer  Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
For Condition: recurrent colon cancer,Stage 4 rectal cancer,adenocarcinoma of the colon,adenocarcinoma of the rectum,recurrent rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
Details: OBJECTIVES: - Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer. - Determine the toxicity of this drug in these patients. - Determine the time to progression and response duration in patients treated with this drug. - Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug. OUTLINE: This is an open-label study. Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is incurable with conventional therapy - Metastatic or recurrent disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan - Disease must be accessible to biopsy - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 3 months Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present) Renal - Creatinine no greater than 1.25 times UNL OR - Creatinine clearance at least 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychiatric illness or social situation that would preclude study compliance - No other uncontrolled concurrent illness - No ongoing or active infection - No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No grade 1 or greater peripheral neuropathy due to prior chemotherapy - No significant traumatic injury within the past 21 days PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior adjuvant chemotherapy allowed - No concurrent cytotoxic chemotherapy Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy - No concurrent radiotherapy to the sole site of measurable disease Surgery - More than 21 days since prior major surgery Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmitOza, Study Chair, Princess Margaret Hospital
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
Princess Margaret Hospital at University Health Network
Toronto, Ontario, M5G 2M9
Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Additional Information:
Study ID Numbers: CDR0000258488; PMH-PHL-012,NCI-5890
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052507
Other Stage 4 Rectal Cancer Studies:
1. Comparison of Adjuvant Chemotherapy Regimens in Treating Patients With Stage II or Stage III Rectal Cancer Who Are Receiving Radiation Therapy and Fluorouracil Before or After Surgery
2. G3139 and Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
3. Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
4. Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
5. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
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