Gemcitabine in Treating Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00007943
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : April 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Primary Purpose: Treatment
Official Title: A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer
Actual Study Start Date : September 2000
Actual Primary Completion Date : February 27, 2001
Actual Study Completion Date : February 27, 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer that has failed at least 1

prior course of fluoropyrimidine-based chemotherapy

Measurable and/or evaluable disease



  • 18 and over

Performance status:

  • 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm3
  • Platelet count at least 100,000/mm3


  • 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


  • Creatinine no greater than 2.0 mg/dL


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • More than 4 weeks since prior radiotherapy


  • More than 4 weeks since prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00007943

United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Paul D. Savage, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00007943     History of Changes
Other Study ID Numbers: REBACDR0000068355
First Posted: April 13, 2004    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: August 2009

Keywords provided by Wake Forest University Health Sciences:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs