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Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer


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

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Trial Information

Phase I Safety and Efficacy Study of an Intravenous Formulation of the Anthracycline Analog, GPX-100, in the Treatment of Metastatic Breast Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of GPX-100 in outpatients with
incurable, solid tumors who are not candidates for effective systemic therapy. II. Evaluate
and quantify the toxicity of GPX-100 in this patient population. III. Identify any changes
in disease status in this patient population.

OUTLINE: This is an open label, multicenter, dose escalation study. Patients receive GPX-100
IV once every 3 weeks. Patients receive 2 courses of treatment in the absence of disease
progression or dose limiting toxicity. Treatment may continue for up to 6 courses (4 courses
with prior doxorubicin) in patients with responding or non-progressing disease. One patient
is entered at each of the first 3 dose levels. Cohorts of 3-6 patients are entered at
subsequent dose levels. The maximum tolerated dose of GPX-100 is defined as the dose at
which no more than 2 instances of dose limiting toxicity are observed in 6 patients.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Incurable, solid tumors in patients who are not candidates for
effective systemic therapy Progressive disease defined as a 25% increase in diameter of
measurable lesions or appearance of new lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
Greater than 16 weeks Hematopoietic: WBC at least 4000/mm3 Platelet count at least
125,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin within normal limits SGOT no
greater than 1.5 times normal (2.5 times normal with disease involvement) Alkaline
phosphatase no greater than 2.5 times normal PT or PTT less than 1.5 times normal Renal:
Creatinine no greater than 1.5 times normal Creatinine clearance at least 60 mL/min
Cardiovascular: No history of congestive heart failure, active ischemic heart disease, or
uncontrolled hypertension No myocardial infarction within the past 6 months Other: Not
pregnant or nursing (negative pregnancy test required) Fertile patients must use effective
contraception No weight loss of 10% or more in the past 3 months No frequent vomiting No
severe anorexia

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed No concurrent
immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for
mitomycin or nitrosoureas) and recovered No greater than 300 mg/m2 cumulative dose of
doxorubicin No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior
hormone therapy No concurrent anticancer hormone therapy Concurrent corticosteroids
allowed Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No
concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior
investigational drug therapy No other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Frederick J. Dechow, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gem Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000066409

NCT ID:

NCT00003403

Start Date:

August 1999

Completion Date:

Related Keywords:

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

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112
Mayo Clinic JacksonvilleJacksonville, Florida  32224