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A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Randomized, Open-Label, Multicenter Phase III Study of 5-FU/Leucovorin With or Without Concomitant SU5416 in Patients With Metastatic Colorectal Cancer

OBJECTIVES: I. Compare the median survival in patients with metastatic colorectal cancer
treated with fluorouracil and leucovorin calcium with or without SU5416. II. Compare the
time to progression, duration of response, and objective response in these patients on these
two regimens. III. Compare the percentage 6 month, 9 month, and one year survival of these
patients on these two regimens. IV. Compare the time to treatment failure in these patients
on these two regimens. V. Determine the health related quality of life of these patients on
these two regimens. VI. Compare the palliative and biologic effects of SU5416 in these
patients. VII. Determine the safety and tolerability of fluorouracil and leucovorin calcium
plus SU5416 in these patients.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to performance status (ECOG 0 vs 1), site of primary disease (colon vs rectum),
measurable or evaluable disease, and prior fluorouracil adjuvant chemotherapy (none vs at
least 1 dose). Patients are randomized to one of two treatment arms: Arm I: Patients receive
leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium
administration weekly for 6 weeks. Arm II: Patients receive leucovorin calcium IV over 2
hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6
weeks, plus SU5416 twice weekly for 8 weeks. Treatment repeats every 8 weeks in the absence
of disease progression or unacceptable toxicity. Quality of life is assessed prior to study,
at weeks 4 and 8 of each course, and then post study. Patients are followed post study at
one month and then every 2 months until death.

PROJECTED ACCRUAL: A total of 710 patients (355 per treatment arm) will be accrued for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed or recurrent,
metastatic colorectal cancer Primary disease was adenocarcinoma of the colon or rectum
Bidimensionally measurable or evaluable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 75,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 2.2
mg/dL AST no greater than 5 times upper limit of normal Renal: Creatinine no greater than
2.0 mg/dL Creatinine clearance at least 50 mL/min Other: Not pregnant Negative pregnancy
test Fertile patients must use effective contraception No known allergy to Cremophor or
Cremophor based drug products No uncontrolled colon or small bowel disorders No other
malignancy within the past 5 years, except: Basal cell skin cancer Carcinoma in situ of
the cervix No other acute or chronic medical or psychiatric condition, or laboratory
abnormality that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy, vaccine therapy,
cytokine therapy, or biologic therapy for metastatic disease No prior angiogenesis
inhibition therapy (e.g., metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1
monoclonal antibody therapy or other experimental drugs acting directly on the VEGF/Flk-1
signaling pathway) Prior antibody therapy, immunotherapy, gene therapy, vaccine therapy,
cytokine therapy, or radioimmunotherapy allowed in adjuvant setting only Concurrent
epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) allowed for anemia,
neutropenia, or thrombocytopenia No concurrent immunotherapy Chemotherapy: No prior
systemic chemotherapy for metastatic disease No prior intra-arterial cytotoxic
chemotherapy No more than one prior course of fluorouracil based adjuvant therapy (e.g.,
intravenous fluorouracil or capecitabine) with the last dose administered at least 6
months ago No prior SU5416 No other concurrent chemotherapy Endocrine therapy: Not
specified Radiotherapy: At least 2 weeks since prior radiotherapy Concurrent localized
palliative radiotherapy allowed unless indicative of disease progression Surgery: At least
4 weeks since prior major surgery (not including surgical placement of a venous access
device) Prior surgical resection of hepatic metastases allowed Other: No prior
investigational therapy for metastatic disease No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Alison L. Hannah, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 1999

Completion Date:

September 2007

Related Keywords:

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



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Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
Alabama Oncology, LLC Montgomery, Alabama  36106-2801
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
New York Medical College Valhalla, New York  10595
University of Texas Medical Branch Galveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Scripps Clinic La Jolla, California  92037
Michigan State University East Lansing, Michigan  48824
Hackensack University Medical Center Hackensack, New Jersey  07601
St. Francis Hospital San Francisco, California  94109
Presbyterian Hospital of Dallas Dallas, Texas  75231
Comprehensive Cancer Care Specialists of Boca Raton Boca Raton, Florida  33428
Office of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee Arcadia, California  91007-7678
Tower Hematology Oncology Medical Group Los Angeles, California  90048
Queen's Medical Center Honolulu, Hawaii  96813
Cancer Center of Boston Boston, Massachusetts  02120
APN-IMPATH Research Corporation Fort Lee, New Jersey  07024
Raleigh Hematology/Oncology Associates - Wake Practice Raleigh, North Carolina  27609
Hematology/Oncology Associates of NE Pennsylvania, P.C. Scranton, Pennsylvania  18510
Associates in Oncology & Hematology Chattanooga, Tennessee  37404
Dial Research Associates, Inc. Nashville, Tennessee  37205