BMS-247550 Plus Carboplatin in Treating Patients With Recurrent or Refractory Solid Tumors
Stopped early · 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 BMS-247550 when given together with carboplatin in treating patients with recurrent or refractory solid tumors. Drugs used in chemotherapy use 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
- NCT00028561
- Run by
- National Cancer Institute (NCI)
- People needed
- 45
- Starts
- 2001-10-01
- Last updated by the study team
- 2013-01-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- Measurable or evaluable disease
- Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD)
- No biliary tract dilation if radiologically guided biopsy of the liver is planned
- No requirement for core biopsy of lung lesion that is not pleural based
- No requirement for laparotomy or thoracotomy solely for biopsy
- No medical condition that would preclude biopsy
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - ECOG 0-1 if being treated at the MTD
- More than 3 months
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- No prior bleeding disorder or unexplained bleeding if being treated at the MTD
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- PT/PTT normal
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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