Overview

Octreotide and Doxorubicin in Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
2002-05-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Octreotide may help doxorubicin kill more cancer cells by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of octreotide and doxorubicin in treating patients who have advanced cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Cancer Institute (NCI)
Treatments:
Doxorubicin
Liposomal doxorubicin
Octreotide
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
specified