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Gemcitabine in Treating Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 6, 2001
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00007943
Brief Title
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
Official Title
A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2000 (Actual)
Primary Completion Date
February 27, 2001 (Actual)
Study Completion Date
February 27, 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D. Savage, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

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Gemcitabine in Treating Patients With Advanced Colorectal Cancer

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