A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of LY231514 followed by irinotecan in
patients with metastatic cancer. II. Determine the quantitative and qualitative toxicity of
LY231514 in combination with irinotecan in these patients. III. Assess plasma
pharmacokinetics in these patients treated with this regimen. IV. Document any antitumor
activity of this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive LY231514 IV over 10 minutes
followed by irinotecan IV over 90 minutes on day 1. Courses repeat every 3 weeks in the
absence of disease progression and unacceptable toxicity. Cohorts of 3-6 patients each
receive escalating doses of LY231514 and irinotecan. If escalation of one drug in the
combination results in unacceptable dose limiting toxicity (DLT), the drug is not escalated
further. Instead, the dose of that drug is decreased to its safe dose, and the second drug
is escalated until unacceptable DLT results. If DLT occurs in 2 of up to 6 patients at any
level, dose escalation is stopped. The maximum tolerated dose is defined as the highest dose
at which fewer than 2 of 6 patients experience DLT during courses 1 or 2.
PROJECTED ACCRUAL: Up to 42 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic solid tumors
that are refractory to standard therapies or for which no potentially effective therapy
exists No leukemia, lymphoma, or multiple myeloma Measurable or evaluable disease No
pleural or peritoneal effusions No symptomatic brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal AST and ALT no
greater than 3 times normal (no greater than 5 times normal if liver involvement present)
Albumin at least 2.5 g/dL Renal: Creatinine clearance at least 45 mL/min Other: Not
pregnant or nursing Fertile patients must use effective contraception during and for 3
months after study No active infection No concurrent serious systemic disorders Body
surface area no greater than 3.0 m2
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At
least 3 weeks since prior chemotherapy and recovered No prior LY231514 or irinotecan No
greater than 6 prior courses of a regimen containing an alkylating agent (except low dose
cisplatin) No greater than 4 prior courses of a carboplatin-containing regimen No prior
mitomycin No other concurrent chemotherapy Endocrine therapy: No concurrent hormone
therapy (except contraceptives or corticosteroids) Radiotherapy: No prior radiotherapy to
25% or more of the bone marrow No prior radiotherapy to the whole pelvis Recovered from
any prior radiotherapy No concurrent radiotherapy Surgery: Not specified Other: At least 4
weeks since any prior investigational agents No concurrent experimental medications No
aspirin or other nonsteroidal antiinflammatory agents for 2 days prior, the day of, and 2
days after the dose of LY231514 (5 days prior to LY231514 for long acting agents such as
piroxicam)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Thomas R. Johnson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
San Antonio Cancer Institute
Authority:
United States: Federal Government
Study ID:
LILLY-H3E-MC-JMAX(a)
NCT ID:
NCT00003711
Start Date:
September 1997
Completion Date:
September 2004
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
| San Antonio Cancer Institute | San Antonio, Texas 78229-3264 |
