Gemcitabine in Treating Patients With Advanced Colorectal Cancer
Status: | Completed |
---|---|
Conditions: | Colorectal Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 8/12/2018 |
Start Date: | September 2000 |
End Date: | February 27, 2001 |
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
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.
they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who
have advanced colorectal cancer.
OBJECTIVES:
- Determine the response rate in patients with advanced colorectal cancer treated with
gemcitabine.
- Determine the toxic effects of this drug in these patients.
- Determine the progression-free survival of patients treated with this drug.
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.
- Determine the response rate in patients with advanced colorectal cancer treated with
gemcitabine.
- Determine the toxic effects of this drug in these patients.
- Determine the progression-free survival of patients treated with this drug.
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.
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has
failed at least 1
prior course of fluoropyrimidine-based chemotherapy
Measurable and/or evaluable disease
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
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
We found this trial at
1
site
Winston-Salem, North Carolina 27157
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