Gemcitabine in Treating Patients With Advanced Colorectal Cancer

NCT ID: NCT00007943

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-01
• Study Completion Date: 2001-02-27

Brief 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.

Detailed 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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul D. Savage, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-59198

Identifier Type: -

Identifier Source: secondary_id

NCI-914

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000068355

Identifier Type: -

Identifier Source: org_study_id