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Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer  Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
For Condition: recurrent rectal cancer,Stage 4 rectal cancer,childhood gastrointestinal cancer,recurrent colon cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): State University of New York ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting of fluorouracil, leucovorin, and gemcitabine in treating patients with recurrent or metastatic colorectal cancer.
Details: OBJECTIVES: I. Determine the response rate and survival of patients with recurrent or metastatic colorectal carcinoma treated with fluorouracil (5-FU), leucovorin calcium, and gemcitabine. II. Evaluate and establish the toxic effect profile of 5-FU, leucovorin calcium, and gemcitabine in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive intravenous leucovorin calcium for 60 minutes and bolus infusions of fluorouracil (5-FU), followed by gemcitabine infusions, weekly for six weeks followed by 2 weeks of rest. The dosage of gemcitabine is increased if fewer than 3 of the first 6 patients experience grade 3-4 toxicities. Phase II proceeds at the maximum tolerated dose (1 dose level below that at which 3 patients experience grade 3-4 toxicities). Patients receive a minimum of two courses of treatment to be considered evaluable for response. Patients with stable disease, partial, or complete remission may continue therapy for up to six treatment cycles. Patients exhibiting disease progression or intolerable toxic effects are removed from the study. PROJECTED ACCRUAL: A total of 63 patients will be accrued.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven recurrent or metastatic primary colorectal carcinoma - Must have measurable disease (evaluable disease acceptable in Phase I) --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Prior chemotherapy for metastatic disease allowed; Prior treatment with 5-FU allowed; Prior treatment with irinotecan allowed - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy (measurable disease must be located outside the prior radiotherapy portal) - Surgery: Not specified - Other: Prior treatment with folinic acid allowed --Patient Characteristics-- - Age: Not specified - Performance Status: ECOG 0-3 - Life Expectancy: Not specified - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 150,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL OR 3.0 mg/dL in patients with liver metastases; Liver enzymes no greater than 3.0 times upper limit of normal (in patients with liver metastases) - Renal: Not specified - Other: Not pregnant or lactating; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StefanMadajewicz, Study Chair, State University of New York
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Additional Information:
Study ID Numbers: CDR0000065561; SUNY-HSC-97-2824,NCI-V97-1256
Study Start Date: April 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003001
Other Stage 4 Rectal Cancer Studies:
1. Liver Resection and Floxuridine Plus Fluorouracil and Leucovorin in Treating Patients With Liver Metastases From Colorectal Cancer
2. Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer
3. Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
4. Antineoplaston Therapy in Treating Patients With Colon Cancer
5. Chloroquinoxaline Sulfonamide in Treating Patients With Stage IV Colorectal Cancer
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
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