Octreotide and Doxorubicin in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laura A. Pollice, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00008073
First received: January 6, 2001
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: doxorubicin hydrochloride
Drug: octreotide acetate
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study Of Octreotide Acetate (Sandostatin) (SMS) As A Biomodulator Of Doxorubicin (DOX)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Study Start Date: January 1996
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008073

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: G. S. Long, MD, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Laura A. Pollice, Clinical Research Manager, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00008073     History of Changes
Other Study ID Numbers: 95-088, CDR0000068373, PCI-IRB-951264, NCI-G00-1886
Study First Received: January 6, 2001
Last Updated: December 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Doxorubicin
Liposomal doxorubicin
Octreotide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 16, 2014