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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Advanced Colorectal Cancer  Gemcitabine in Treating Patients With Advanced Colorectal Cancer
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
For Condition: recurrent rectal cancer,stage 3 rectal cancer,recurrent colon cancer,stage 3 colon cancer,Stage 4 rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Comprehensive Cancer Center of Wake Forest University
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 gemcitabine in treating patients who have advanced colorectal cancer.
Details: OBJECTIVES: I. Determine the response rate in patients with advanced colorectal cancer treated with gemcitabine. II. Determine the toxic effects of this drug in these patients. III. Determine the progression-free survival of patients treated with this drug. PROTOCOL OUTLINE: This is a multicenter study. Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced colorectal cancer that has failed at least 1 prior course of fluoropyrimidine-based chemotherapy - Measurable and/or evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No more than 3 prior chemotherapy regimens; Must have 1 prior fluorouracil-based regimen and 1 other cytotoxic agent (e.g., irinotecan); More than 4 weeks since prior chemotherapy; Prior gemcitabine allowed; No other concurrent antineoplastic therapy - Endocrine therapy: Not specified - Radiotherapy: More than 4 weeks since prior radiotherapy - Surgery: More than 4 weeks since prior surgery --Patient Characteristics-- - Age: 18 and over - Performance status: 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); ALT and/or AST no greater than 3 times ULN (no greater than 10 times ULN if secondary to hepatic involvement by tumor) - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No history of cardiac arrhythmias requiring chronic treatment beyond an acute event (e.g., arrhythmias during severe electrolyte abnormalities allowed); No active cardiac disease requiring treatment other than hypertension, stable angina, or chronic valvular disease - Other: No other malignancy within the past 5 years except curatively treated (including surgically cured) cancer; No serious medical or psychiatric illness that would preclude study; No active uncontrolled bacterial, fungal, or viral infection; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulSavage, Study Chair, Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000068355; NCI-914,CCCWFU-59198
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007943
Other Stage 3 Colon Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
3. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
4. Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
5. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
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