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Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer


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

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Trial Information

Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer


OBJECTIVES:

Primary

- Determine the tumor response rate in patients with metastatic colorectal cancer treated
with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line
treatment.

Secondary

- Determine the time to tumor progression, time to treatment failure, and overall
survival of patients treated with this regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the quality of life of patients treated with this regimen.

- Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia,
diarrhea, or neutropenia) or response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and
leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every
3 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each chemotherapy course, and at the end of
treatment.

Patients are followed every 3 months until 5 years after registration.

PROJECTED ACCRUAL: A total of 50-105 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of colorectal adenocarcinoma

- Metastatic disease

- Not curable by surgery or amenable to radiotherapy with curative intent

- Measurable disease

- Patients with only lesions measuring ≥ 1 cm but < 2 cm must use spiral CT scan
for pre- and post-treatment tumor assessments

- No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- AST ≤ 5 times upper limit of normal (ULN)

- Bilirubin ≤ 0.5 mg/dL above ULN

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No unstable angina

- No symptomatic congestive heart failure

- No serious uncontrolled cardiac arrhythmia

Pulmonary

- No prior clinical diagnosis of interstitial lung disease

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active or uncontrolled infection

- No other concurrent serious illness

- No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with
function

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or adequately treated noninvasive carcinomas

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent sargramostim (GM-CSF)

Chemotherapy

- At least 6 months since prior adjuvant chemotherapy

- No prior fluorouracil for advanced colorectal cancer

- No prior adjuvant oxaliplatin

- No prior adjuvant irinotecan

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to > 25% of bone marrow

Surgery

- At least 4 weeks since prior major surgery

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Charles Erlichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000357571

NCT ID:

NCT00080951

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

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