Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill more tumor cells. This randomized phase I trial is studying the side effects and best way to give irinotecan and thalidomide in treating patients with metastatic or unresectable solid tumors
Key facts
- Study ID
- NCT00062127
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2003-04-01
- Last updated by the study team
- 2013-01-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed malignant solid tumor
- Metastatic or unresectable
- Standard curative or palliative therapy is no longer effective or does not exist
- Measurable or assessable disease
- No uncontrolled brain metastases
- Patients with brain metastases are eligible provided the following are true:
- Stable neurologic status
- At least 4 weeks since prior steroids or anticonvulsants
- No neurologic dysfunction that would confound evaluation
- Performance status - Karnofsky 70-100%
- More than 12 weeks
- WBC at least 3,000/mm\^3
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of inflammatory bowel disease requiring therapy
- No chronic diarrhea syndromes
- No paralytic ileus
- Not pregnant or nursing
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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