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A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Pharmacokinetic Study of Single Dose Intravenous CA4P in Patients With Advanced Cancer

OBJECTIVES: I. Determine the maximum tolerated dose of combretastatin A4 phosphate when
administered at single doses every 21 days in patients with advanced solid tumors. II.
Determine both the toxicity and dose limiting toxicity of this regimen in these patients.
III. Determine the plasma and urine pharmacokinetics of combretastatin A4 and combretastatin
A4 phosphate. IV. Gather preliminary data regarding possible antitumor effects in those
patients with measurable disease.

OUTLINE: This is an open label, dose escalation study. Patients receive combretastatin A4
phosphate IV over 10-60 minutes. Treatment repeats every 3 weeks in the absence of
unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating
doses of combretastatin A4 phosphate until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose limiting toxicity. Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A maximum of 21 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced solid tumors that
have failed standard therapy or for which no curative therapy exists No leukemia,
lymphoma, or multiple myeloma No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal
SGOT/SGPT no greater than 3 times upper limit of normal (ULN) PT/PTT less than ULN OR
International normalized ratio (INR) less than 1.1 Renal: Creatinine no greater than 2.0
mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No clear evidence of
acute ischemic heart disease on EKG No history of myocardial infarction within past 6
months No history of angina No peripheral vascular disorder Neurologic: No active seizure
disorder Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No evidence of hematemesis, melena, or hematochezia No history of
inflammatory bowel disease, autoimmune disease, or bleeding disorders No Type I diabetes
mellitus or Type II diabetes with peripheral vascular disorders No active infections or
any serious concurrent systemic disorders incompatible with study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered No other
concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since prior radiotherapy and recovered Surgery: At least 6 weeks since prior major
surgery Other: At least 4 weeks since any other prior investigational agent No concurrent
anticonvulsant therapy No concurrent aspirin greater than 100 mg per day, heparin, or
nonsteroidal antiinflammatory medication No concurrent calcium channel blockers,
antiarrhythmias, or anti-angina therapy Concurrent beta-blocking agents for hypertension
or anxiety allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

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



Ireland Cancer Center Cleveland, Ohio  44106-5065