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Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer Clinical research trials and Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer. Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer  Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
For Condition: recurrent colon cancer,adenocarcinoma of the rectum,Stage 4 rectal cancer,recurrent rectal cancer,adenocarcinoma of the colon,stage 4 colon cancer
Status: Recruiting
Sponsor(s): Mount Sinai Medical Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor. Combining more than one drug with interferon-gamma may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining fluorouracil with phenylbutyrate, indomethacin, and interferon-gamma in treating patients who have stage IV colorectal cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of fluorouracil administered with phenylbutyrate, indomethacin, and interferon gamma in patients with advanced colorectal adenocarcinoma. - Determine the toxic effects of this regimen in these patients. - Determine the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of fluorouracil (5-FU). - Patients receive 5-FU IV over 24 hours on day 1; phenylbutyrate IV over 120 hours and oral indomethacin daily on days 2-6; and interferon gamma subcutaneously on days 2, 4, and 6. Courses repeat weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity (DLT). - Phase II :Patients receive 5-FU, phenylbutyrate, indomethacin, and interferon gamma as in phase I at the MTD. Patients are followed for survival. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for the phase I portion of this study and approximately 46 patients will be accrued for the phase II portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV colorectal adenocarcinoma - Bidimensionally measurable disease on x-ray, CT scan, or MRI required for phase II patients - No brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - At least 16 weeks Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: - Creatinine no greater than 2 times ULN Cardiovascular: - No New York Heart Association class III-IV heart disease Nutritional: - Adequate oral intake - No diarrhea Other: - No other serious concurrent illness - No dependence on immunosuppressive drugs, including corticosteroids - No other malignancy within the past 5 years except: - Inactive nonmelanoma skin cancer - Carcinoma in situ of the cervix - Grade I bladder cancer - No allergy to interferon gamma or E. coli-derived products - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for metastatic disease - At least 12 months since prior adjuvant chemotherapy Endocrine therapy - No concurrent corticosteroids Radiotherapy - At least 12 months since prior adjuvant radiotherapy Surgery - Not specified Other - No concurrent immunosuppressive drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaxSung, Study Chair, Mount Sinai Medical Center
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Max Sung 212-241-7902
Additional Information:
Study ID Numbers: CDR0000064879; MTS-96322-ME,NCI-T96-0015O
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002796
Other Stage 4 Rectal Cancer Studies:
1. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
2. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
3. Neoadjuvant and Adjuvant Capecitabine and Oxaliplatin in Treating Patients With Resectable Liver Metastases Secondary to Colorectal Cancer
4. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
5. Capecitabine in Treating Older Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
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Fluorouracil, Phenylbutyrate, Indomethacin, and Interferon Gamma in Treating Patients With Advanced Colorectal Cancer
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