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Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Clinical research trials and Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin. Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin clinical trial. Subjects often receive the most expert healthcare possible for their Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin  Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
For Condition: adult solid tumor,childhood solid tumor,Rectal Cancer,Colon Cancer,carcinoma of unknown primary
Status: Recruiting
Sponsor(s): St. Jude Children's Research Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastaticadenocarcinoma (cancer) of unknown primary origin.
Details: OBJECTIVES: - Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium. - Determine the disease-free survival of patients with stage III colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: Patients with stage III colorectal carcinoma (post surgical resection) receive irinotecan IV over 1 hour on days 1-5 and days 8-12. Treatment repeats every 3 weeks for 2 courses. Beginning on week 7, patients receive pelvic irradiation, leucovorin calcium IV over 4 hours, and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5. Treatment repeats every 3 weeks for a total of 2 courses. Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year. Patients with stage IV colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy (irinotecan, fluorouracil, and leucovorin calcium) with pelvic irradiation (if indicated). Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy, even in the absence of visible tumor regression. Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor. Patients with complete response (CR) or partial response (PR) after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or progressive disease after 2 courses of irinotecan and SD, CR, or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /24 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically proven previously untreated stage III or stage IV colorectal carcinoma - Other carcinomas refractory to standard treatment - Metastatic adenocarcinoma of unknown primary site PATIENT CHARACTERISTICS: Age: - Under 25 Performance status: - ECOG 0-2 Life expectancy: - At least 8 weeks Hematopoietic: - Hemoglobin at least 10.0 g/dL - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Albumin greater than 3.0 g/dL - Bilirubin less than 1.5 mg/dL - SGOT or SGPT less than 2 times normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 80 mL/min - Urinalysis normal Other: - Blood glucose normal - Electrolytes normal - Prior curatively treated childhood cancer allowed - Weight greater than 10th percentile for height - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WayneFurman, Study Chair, St. Jude Children's Research Hospital
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Additional Information:
Study ID Numbers: CDR0000067216; SJCRH-CACO5,NCI-G99-1554
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004005
Other Childhood Solid Tumor Studies:
1. Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
2. Irinotecan in Treating Children With Refractory Solid Tumors
3. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
4. Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
5. Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer
Related Studies:
Other childhood solid tumor Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin
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