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SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical research trials and SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer  SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer
Status: Suspended
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
Details: OBJECTIVES: - Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer. - Determine the qualitative and quantitative toxicity of this drug in these patients. - Determine the time to progression and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal cancer - Locally recurrent or metastatic disease - Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 120,000/mm^3 Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary: - DLCO at least 80% predicted - FVC at least 80% predicted - No history of significant pulmonary disease - No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma) Other: - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix - No other serious illness or medical condition that would preclude study - No ongoing or active uncontrolled infection - No history of significant neurologic or psychiatric disorder that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - Prior adjuvant chemotherapy allowed - No prior nitrosoureas - No prior second-line chemotherapy for recurrent or metastatic disease - At least 4 weeks since prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - Prior radiotherapy as part of primary therapy allowed - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - Prior surgery as part of primary therapy allowed - Prior reoperation for recurrent disease allowed - At least 2 weeks since prior surgery other than biopsy Other: - At least 4 weeks since prior investigational agent - No other concurrent investigational agents or therapy - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RalphWong, Study Chair, CancerCare Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Hopital Notre- Dame du CHUM
Montreal, Quebec, H2L 4MI
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
Additional Information:
Study ID Numbers: CDR0000069113; CAN-NCIC-IND146,NCI-NCIC-146
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028015
Other Stage 4 Colon Cancer Studies:
1. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
2. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
3. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
4. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
5. OSI-7904L and Oxaliplatin in Treating Patients With Refractory or Recurrent Advanced Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Ontario Clinical Trials
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SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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