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Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs. 5-FU With IM862 With Cross-Over to CPT-11 vs. CPT-11 With IM862


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

Thank you

Trial Information

Phase II Randomized Placebo-Controlled Double-Blinded Study With 5-FU vs. 5-FU With IM862 With Cross-Over to CPT-11 vs. CPT-11 With IM862


OBJECTIVES: I. Compare the efficacy of fluorouracil with or without IM-862 in terms of
progression free survival in patients with previously untreated or recurrent metastatic
adenocarcinoma of the colon or rectum. II. Determine the toxicity of IM-862 and fluorouracil
in these patients. III. Determine the efficacy of IM-862 in combination with irinotecan in
terms of progression free survival in patients who have disease progression after receiving
fluorouracil. IV. Obtain preliminary data on molecular markers of response and time to
progression by determining levels of genes involved in adhesion, angiogenesis, apoptosis,
and drug resistance prior to and during chemotherapy. V. Determine the molecular correlates
for response and time to progression through analysis of serum and urine markers of
angiogenesis, such as vascular endothelial growth factor and fibroblast growth factor, in
patients treated with IM-862 in combination with fluorouracil or irinotecan. VI. Compare the
quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. Patients
are randomized to one of two treatment arms: Arm I: Patients receive fluorouracil IV
continuously on days 1-21 and IM-862 intranasally three times daily on days 1-28. Courses
repeat every 4 weeks in the absence of disease progression. Patients who develop disease
progression are taken off fluorouracil and IM-862, and then receive irinotecan IV over 90
minutes weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease
progression. Arm II: Patients receive fluorouracil as in arm I and placebo intranasally
three times daily on days 1-28. Courses repeat every 4 weeks in the absence of disease
progression. Patients who develop disease progression are taken off fluorouracil and
placebo, and then receive irinotecan and IM-862 as in arm I on days 1-42. Courses repeat
every 6 weeks in the absence of disease progression. Quality of life is assessed prior to
study, and then prior to every course during study. Patients are followed for a minimum of 6
months.

PROJECTED ACCRUAL: A total of 66 patients (33 per arm) will be accrued for this study within
26-27 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or
rectum Previously untreated OR Recurrent with a disease free period of at least 1 year
Measurable or evaluable disease Tumor must be accessible for biopsy No brain metastasis

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute granulocyte count greater than 1,000/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal
(ULN) (no greater than 3 times ULN if liver metastasis present) AST or ALT no greater than
2 times ULN (no greater than 5 times ULN if liver metastasis present) Renal: Creatinine no
greater than 1.25 times ULN Cardiovascular: No myocardial infarction within the past year
No congestive heart failure Other: No other malignancy within the past 5 years except
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the
cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for at least 6 months after study No medical, social, or
psychological factor that would interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior adjuvant immunotherapy with monoclonal
antibody 17-1A allowed No prior IM-862 Chemotherapy: At least 1 year since prior
chemotherapy for patients with recurrent metastatic adenocarcinoma of the colon or rectum
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy No concurrent
radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Heinz-Josef Lenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068052 (3C-99-3)

NCT ID:

NCT00006037

Start Date:

November 1999

Completion Date:

November 2001

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

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804