A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
OBJECTIVES:
Primary
- Determine the optimal loading and maintenance doses of selenium necessary to achieve
selenium concentrations exceeding 15 μM when administered with irinotecan in patients
with advanced solid tumors.
Secondary
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
- Determine any observed tumor response to this regimen in these patients.
OUTLINE: This is a dose-escalation study of selenium.
Patients receive a loading dose* of oral selenium twice daily on days -6 to 0. Patients then
receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1,
8, 15, and 22. Courses repeat every 42 days in the absence of disease progression or
unacceptable toxicity.
NOTE: *The loading dose is administered prior to course 1 only.
Cohorts of 3-6 patients receive escalating doses of selenium until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 2-36 patients will be accrued for this study within 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Metastatic or unresectable disease
- Standard curative or palliative treatments do not exist or are no longer effective OR
treatment with single-agent irinotecan does not constitute a reasonable treatment
option
- No known untreated or progressive brain metastases
- Previously treated brain metastases allowed provided all of the following are
true:
- No significant neurological deficit
- No requirement for anti-epileptic medications
- Disease stable by brain CT scan or MRI
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
- AST and ALT ≤ 3 times upper limit of normal
- Albumin ≥ 3.0 g/dL
- No Gilbert's disease
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No clinically significant cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to receive oral medications
- No active inflammatory bowel disease or chronic diarrhea
- No known HIV positivity
- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to study drugs
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent Hypericum perforatum (St. John's wort)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Marwan Fakih, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000427616
NCT ID:
NCT00112892
Start Date:
August 2004
Completion Date:
December 2007
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
