Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery
Completed · Phase 1
Conditions studied: Gastrointestinal Stromal Tumor, Recurrent Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
In brief
This phase I trial is studying the side effects and best dose of alvocidib when given with doxorubicin hydrochloride in treating patients with metastatic or recurrent sarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride and alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also help doxorubicin hydrochloride work better by making tumor cells more sensitive to the drug. Giving more than one drug may kill more tumor cells
Key facts
- Study ID
- NCT00098579
- Run by
- National Cancer Institute (NCI)
- People needed
- 36
- Starts
- 2004-10-01
- Last updated by the study team
- 2013-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed soft-tissue sarcoma*
- Unresectable disease
- Locally recurrent or metastatic disease
- Disease amenable to biopsy (patients treated at the maximum tolerated dose only)
- No known prior or concurrent brain metastases
- Performance status - Karnofsky 60-100%
- Performance status - ECOG 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 60 mL/min
- Ejection fraction ≥ 50% by MUGA or echocardiogram
- No uncontrolled hypertension
- No myocardial infarction
- No New York Heart Association class II-IV congestive heart failure
- No unstable angina
- No serious cardiac arrhythmia requiring medication
- No peripheral vascular disease ≥ grade 2 within the past year
- No other clinically significant cardiac disease
- No prior deep vein thrombosis
- No other prior vascular thrombus
- No prior pulmonary embolism
- Not pregnant or nursing
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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