Gemcitabine in Treating Patients With Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007943
• Other study ID #: REBACDR0000068355
• Secondary ID: CCCWFU-59198NCI-
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2000
• Est. completion date: February 27, 2001

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 27, 2001
• Est. primary completion date: February 27, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,