Gemcitabine in Treating Patients With Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 2001-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemcitabine

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