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Octreotide and Doxorubicin in Treating Patients With Advanced Cancer



Octreotide and Doxorubicin in Treating Patients With Advanced Cancer

For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: Patient Abstract available in the near future.
Details: 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. PROTOCOL 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignancy ineligible for therapy of proven greater benefit than doxorubicin alone - Measurable or evaluable disease --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ScottLong,  Study Chair,  University of Pittsburgh Cancer Institute

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213
United States
 


Additional Information:
Study ID Numbers:  CDR0000068373;  NCI-G00-1886,PCI-95-088,PCI-IRB-951264
Study Start Date: January 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008073

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
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3. VNP20009 in Treating Patients With Advanced Solid Tumors

4. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

5. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer

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