Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: doxorubicin  Drug: octreotide	Phase I

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

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

Study chairs or principal investigators

Scott Long,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000068373; PCI-95-088; NCI-G00-1886; PCI-IRB-951264
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008073
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08