Flavopiridol, Gemcitabine, and Irinotecan in Treating Patients With Unresectable or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of flavopiridol when given together with gemcitabine and irinotecan in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as flavopiridol, gemcitabine, and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
Key facts
- Study ID
- NCT00079352
- Run by
- National Cancer Institute (NCI)
- People needed
- 24
- Starts
- 2004-04-01
- Last updated by the study team
- 2013-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor that is metastatic or unresectable
- Standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- No venous thrombosis within the past 6 months
- No thrombotic cerebrovascular accident within the past 6 months
- No myocardial infarction within the past 6 months
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No ongoing or active infection
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
- No other concurrent uncontrolled medical condition that would preclude study participation
- No psychiatric illness or social situation that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
Where it is running
- University of New Mexico — Albuquerque, New Mexico, United States
Full record on ClinicalTrials.gov
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