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Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer

Phase 1
18 Years
Not Enrolling
Colorectal Cancer, Metastatic Cancer

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Trial Information

Pilot Study of FLT3 Ligand Prior to Resection of Hepatic Metastases of Colorectal Cancer

OBJECTIVES: I. Evaluate the safety and feasibility of administering flt3 ligand to patients
with hepatic metastases from colorectal cancer prior to surgical resection.

OUTLINE: Patients receive flt3 ligand subcutaneously for 14 days followed by 14 days of
rest. This course of therapy may be repeated for a total of 3 courses. Leukapheresis is
performed on day 15 of the last course of Flt3 ligand. Patients undergo restaging and
metastasis resection. Patients are followed every 3 months for the first year, every 6
months for the second year, and yearly thereafter.

PROJECTED ACCRUAL: This study will accrue 12 patients in 1 year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic colon cancer expressing
carcinoembryonic antigen (CEA) At least 50% of tumor cells must express CEA with at least
moderate intensity Resectable hepatic metastases or other site of metastatic colon cancer
that is resectable (e.g., lung metastases)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1000/mm3
Absolute lymphocyte count at least 1000/mm3 Hemoglobin at least 9 mg/dL Platelet count at
least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No hepatic disease Renal:
Creatinine less than 2.5 mg/dL Cardiovascular: No ongoing cardiac disease No New York
Heart Association class III or IV heart disease Pulmonary: No ongoing pulmonary disease
such as: Asthma Chronic obstructive pulmonary disease (COPD) Active radiation- or
drug-induced pneumonitis Other: Not pregnant or nursing Fertile patients must use
effective contraception No history of autoimmune disease such as but not limited to:
Inflammatory bowel disease Systemic lupus erythematosus Ankylosing spondylitis Scleroderma
Type I diabetes Multiple sclerosis No other serious ongoing chronic or acute illness No
medical or psychological impediment to study compliance No concurrent or prior second
malignancy except: Nonmelanoma skin cancer Controlled superficial bladder cancer within
the last 5 years No active or chronic infection including: Urinary tract infection HIV
Viral hepatitis

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids No concurrent
hormone therapy Radiotherapy: No concurrent radiation therapy Surgery: No specified Other:
No immunosuppressives such as: Azathioprine Cyclosporine A

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Morse, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

May 2001

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • lung metastases
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Duke Comprehensive Cancer Center Durham, North Carolina  27710