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Phase I Study of Endostatin in Advanced Cancer Patients


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Endostatin in Advanced Cancer Patients


OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in
patients with advanced refractory solid tumors. II. Determine the qualitative and
quantitative nature of the toxicities encountered with endostatin in this patient
population. III. Evaluate the basic pharmacokinetics and metabolism of endostatin by
measurement of plasma levels by EIA and mass spectrometry in this patient population. IV.
Investigate the relationship between pharmacokinetic parameters and toxicity in this patient
population. V. Evaluate biologic evidence of angiogenesis inhibition in patients receiving
endostatin.

OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily
for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily
therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3
patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicities.

PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory solid tumor for
which no curative therapy exists Bidimensionally measurable or evaluable disease
accessible to biopsy No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least
2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/SGOT no
greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5
mg/dL OR Creatinine clearance greater than 60 mL/min Other: No serious active infection
Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since prior radiotherapy and recovered Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James P. Thomas, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067532

NCT ID:

NCT00004872

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792