NCT00112892CompletedPhase 1
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
Roswell Park Cancer Institute1 site in 1 country36 target enrollmentStarted: August 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenium may allow higher doses of irinotecan to be given. Giving irinotecan together with selenium may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Performance status
- •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
- •Bilirubin normal
- •AST and ALT ≤ 3 times upper limit of normal
- •Albumin ≥ 3.0 g/dL
- •No Gilbert's disease
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No clinically significant cardiac arrhythmia
- •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
- •Not specified
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
- +1 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum tolerated dose
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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