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A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer


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

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Trial Information

A Phase II Trial of Preoperative Irinotecan (CPT-11) in Patients With High-Risk Resectable Metastatic Colorectal Cancer


OBJECTIVES: I. Evaluate the clinical usefulness of preoperative irinotecan in patients with
high risk, technically resectable metastatic colorectal cancer that is refractory to
fluorouracil. II. Evaluate prospectively the relationship between expression of selected
molecular determinants of response and clinical responsiveness to irinotecan in these
patients. III. Determine the effect of treatment with irinotecan on the expression of
putative response determinants in these patients.

OUTLINE: This is an open label study. Patients receive irinotecan IV over 90 minutes weekly
for 4 consecutive weeks. Course repeats every 6 weeks. After 2 courses, CT scan is obtained
and patients showing evidence of disease that is still amenable to surgical resection
undergo surgery. Approximately 4-8 weeks after surgical resection, patients receive 3
additional courses of irinotecan in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for 2 years and then every 6 months for years
3 and 4.

PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed technically resectable metastatic
colorectal cancer that is high risk for relapse Must meet one of the following criteria:
Metastatic colorectal cancer confined to liver plus portal lymph nodes Recurrent
metastatic colorectal cancer confined to liver after first hepatic resection Metastatic
colorectal cancer confined to lung plus liver Metastatic colorectal cancer confined to
liver with MSKCC risk factor score greater than 4 Metastatic colorectal cancer confined to
lung, with either greater than 1 nodule and/or less than 3 years disease free survival
Metastatic colorectal cancer confined to ovary Metastatic colorectal cancer confined to a
single intraabdominal lymph node Must have failed fluorouracil-based chemotherapy for
metastatic disease, received fluorouracil-based chemotherapy in adjuvant setting, have
tumor with measured thymidylate synthase level greater than 4.0, or have lung metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL
Cardiovascular: No myocardial infarction in the last 6 months Other: No other prior
malignancy in the past 5 years except adequately treated basal cell or squamous cell skin
cancer or carcinoma in situ of the cervix No active or uncontrolled infection No
psychiatric or other disorders No other concurrent disease that would preclude entry into
this study Not pregnant or nursing Effective contraception required of all fertile
patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior irinotecan or other camptothecins Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-057

NCT ID:

NCT00003544

Start Date:

June 1998

Completion Date:

March 2001

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021