Octreotide and Doxorubicin in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00008073
Recruitment Status : Completed
First Posted : May 24, 2004
Last Update Posted : December 19, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Laura A. Pollice, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: doxorubicin hydrochloride Drug: octreotide acetate Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study Of Octreotide Acetate (Sandostatin) (SMS) As A Biomodulator Of Doxorubicin (DOX)
Study Start Date : January 1996
Actual Primary Completion Date : May 2002
Actual Study Completion Date : May 2002

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00008073

United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Study Chair: G. S. Long, MD, PhD University of Pittsburgh

Responsible Party: Laura A. Pollice, Clinical Research Manager, University of Pittsburgh Identifier: NCT00008073     History of Changes
Other Study ID Numbers: 95-088
CDR0000068373 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 24, 2004    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Keywords provided by Laura A. Pollice, University of Pittsburgh:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal