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Phase I Study Of Octreotide Acetate (Sandostatin) (SMS) As A Biomodulator Of Doxorubicin (DOX)

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

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Trial Information

Phase I Study Of Octreotide Acetate (Sandostatin) (SMS) As A Biomodulator Of Doxorubicin (DOX)

OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of octreotide administered
with doxorubicin in patients with advanced cancer. II. Determine the pharmacokinetics and
pharmacodynamics of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of octreotide. Patients receive doxorubicin IV over
5 minutes on day 1 of course 1. For all subsequent courses, patients receive octreotide SC
continuously on days 1-7 and doxorubicin IV over 5 minutes on day 5. Treatment continues
every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with
stable or responsive disease after 3 courses of therapy receive a maximum of 6 additional
courses. Cohorts of 3-6 patients receive escalating doses of octreotide 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.

PROJECTED ACCRUAL: Approximately 21-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignancy ineligible for therapy of
proven greater benefit than doxorubicin alone Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 2 mg/dL SGOT no greater than 4 times normal Renal:
Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 50% No compensated or
uncompensated congestive heart failure Other: Not pregnant Fertile patients must use
effective contraception during and for 2 months after study No history of gallstones with
gallbladder in place

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or
nitrosourea) and recovered No more than 240 mg/m2 total cumulative dose of prior
doxorubicin Endocrine therapy: Prior octreotide allowed Recovered from prior octreotide
Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

G. S. Long, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

January 1996

Completion Date:

Related Keywords:

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



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213