Status:
COMPLETED
Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 h...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00112892
Start Date
August 1 2004
End Date
December 1 2007
Last Update
January 13 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001