Know Cancer

or
forgot password

A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Phase II Study Of Twenty-Four Hour Infusion Gemcitabine For Advanced Colorectal Cancer


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul D. Savage, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000068355

NCT ID:

NCT00007943

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082