Colon Cancer Clinical Trial

Gemcitabine in Treating Patients With Advanced Colorectal Cancer

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT00007943

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

15

Study ID:

NCT00007943

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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