Gemcitabine in Treating Patients With Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00007943
First received: January 6, 2001
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Study Start Date: September 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007943

Locations
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 Baptist Health
Investigators
Study Chair: Paul D. Savage, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00007943     History of Changes
Other Study ID Numbers: CDR0000068355, CCCWFU-59198, NCI-914
Study First Received: January 6, 2001
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014