Clinical trial NCT00007943: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Paul D. Savage, MD
role: STUDY_CHAIR
References: