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A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer


OBJECTIVES: I. Compare the survival of patients with previously untreated metastatic
colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan with or
without SU5416. II. Compare the antitumor efficacy of these regimens in these patients. III.
Evaluate the additional measures of clinical benefit in patients treated with these
regimens. IV. Determine the relative safety profile of these regimens in these patients. V.
Assess quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to ECOG performance status (0 vs 1), baseline lactate dehydrogenase (normal vs
elevated), and treatment regimen. Patients are randomized to 1 of 2 treatment arms by 2
different regimens (Saltz vs de Gramont). Regimen I (Saltz): Arm IA: Patients receive SU5416
IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Patients also
receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 5-10 minutes, and
fluorouracil IV over 5-10 minutes on days 1, 8, 15, and 22. Arm IIA: Patients receive
irinotecan, leucovorin calcium, and fluorouracil as in arm I. Treatment in both arms repeats
every 6 weeks in the absence of disease progression or unacceptable toxicity. Regimen II (de
Gramont): Arm IB: Patients receive SU5416 as in arm IA. Patients also receive irinotecan IV
over 30-90 minutes on days 1, 15, and 29 and leucovorin calcium IV over 2 hours and
fluorouracil IV over 2 hours on days 1, 2, 15, 16, 29, and 30. Arm IIB: Patients receive
irinotecan, leucovorin calcium, and fluorouracil as in arm IB. Treatment in both arms
repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at the beginning of each course, and then at the
end of treatment. Patients are followed at 1 month and then every 2 months for 4 years.

PROJECTED ACCRUAL: A total of 1,270 patients (635 per treatment arm) will be accrued for
this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum
Newly diagnosed or recurrent disease Measurable or evaluable metastatic disease that is
previously untreated No known brain or leptomeningeal metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.8
times upper limit of normal (ULN) SGOT no greater than 5 times ULN Alkaline phosphatase no
greater than 5 times ULN Lactate dehydrogenase no greater than 5 times ULN Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within
the past 6 months No ongoing unstable angina No symptomatic congestive heart failure No
serious uncontrolled cardiac dysrhythmia No stroke within the past 6 months
Gastrointestinal: No active inflammatory bowel disease No significant bowel obstruction No
chronic diarrhea grade 2 or greater Other: HIV negative No AIDS-related illness No known
allergy to Cremaphor-containing products, irinotecan, fluorouracil, or to both warfarin
(or similar oral anticoagulants) and low-molecular weight heparin No other malignancy
within the past 5 years except nonmelanoma skin cancer No other severe acute or chronic
medical or psychiatric condition or laboratory abnormality that would preclude study Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior adjuvant
antibody therapy, immunotherapy, gene therapy, vaccine therapy, or cytokine therapy No
prior systemic biologic therapy for metastatic disease, including antibody therapy,
immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or angiogenesis inhibitors
(e.g., SU5416, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal
antibody) No concurrent antibody therapy, immunotherapy, gene therapy, vaccine therapy, or
angiogenesis inhibitors No concurrent sargramostim (GM-CSF) Chemotherapy: At least 6
months since prior adjuvant chemotherapy (e.g., fluorouracil, leucovorin calcium,
levamisole, irinotecan, oxaliplatin, capecitabine, fluorouracil-uracil, or other cytotoxic
agents) No prior systemic chemotherapy for metastatic disease No prior intra-arterial
cytotoxic chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine
therapy: No concurrent anticancer hormonal therapy Radiotherapy: At least 6 months since
prior adjuvant radioimmunotherapy or radiotherapy and recovered No concurrent radiotherapy
Surgery: Recovered from prior surgery Other: At least 6 months since other prior adjuvant
therapy No other prior systemic anticancer therapy for metastatic disease No other
concurrent anticancer therapy No other concurrent experimental drugs No concurrent
participation in another clinical trial

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lee S. Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068766

NCT ID:

NCT00021281

Start Date:

December 2000

Completion Date:

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781