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A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy


I. Determine the optimal biologic dose of endostatin in patients with advanced solid tumors.

II. Determine the safety and tolerability of this regimen in these patients. III. Determine
the extent, frequency, and duration of tumor response in these patients on this regimen.

IV. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this
regimen in these patients.

V. Determine the recommended phase II dose and schedule of this regimen.

OUTLINE: This is a dose escalation study.

Patients undergo a biopsy during prestudy and after the second course of treatment. Patients
receive endostatin IV daily for 4 weeks. Patients on dose level 1-6 receive endostatin over
20 minutes. Patients on dose level 7 receive endostatin over 40 minutes, with no treatment
on day 2 of the first course only. Treatment continues every 4 weeks in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 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 toxicity.

Patients are followed for 1 month.

Inclusion Criteria


- Histologically proven advanced solid tumor for which no standard curative therapy

- Must be amenable to biopsy At least 1 site of measurable disease outside of
irradiated field

- No brain metastases by CT or MRI scan


- Age: 18 and over

- Performance status: ECOG 0-1

- WBC greater than 3,000/mm3

- Absolute neutrophil count greater than 1,500/mm3

- Platelet count greater than 100,000/mm3

- Hemoglobin greater than 10 g/dL

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- ALT and AST less than 2.0 times ULN

- PT/PTT less than 1.5 times ULN

- Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent uncontrolled medical or psychiatric disorder

- No history of bleeding diathesis


- No concurrent over the counter biologic agents (e.g., shark cartilage)

- At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin)

- No more than 3 prior chemotherapy regimens for metastatic or recurrent disease (ECOG

- Prior adjuvant chemotherapy for nonmetastatic disease allowed

- Concurrent stable dose of hormone replacement therapy allowed

- At least 3 weeks since prior radiotherapy

- No concurrent radiotherapy

- At least 24 hours since minor surgery (e.g., central venous placement)

- At least 4 weeks since major surgery (e.g., laparotomy, thoracotomy, or craniotomy)

- At least 30 days since other prior investigational agents

- No concurrent herbal remedies

- No concurrent usage of products containing heparin

- No other concurrent anticancer therapy

- Concurrent multivitamins allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Roy S. Herbst, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009