Oxaliplatin and Bortezomib in Treating Patients With Advanced Cancer
Stopped early · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
Phase I trial to study the effect on the body of combining oxaliplatin with bortezomib in treating patients who have metastatic or unresectable cancer. Drugs used in chemotherapy such as oxaliplatin use different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. Combining oxaliplatin with bortezomib may kill more cancer cells
Key facts
- Study ID
- NCT00066625
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2003-07-01
- Last updated by the study team
- 2013-02-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed malignancy for which standard curative or palliative measures do not exist or are no longer effective
- Metastatic or unresectable disease
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100
- More than 6 months
- 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 5 times upper limit of normal
- Creatinine no greater than 1.5 mg/dL
- 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
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to any platinum or other study agents
- No pre-existing peripheral neuropathy
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- Prior thalidomide allowed provided patient has no clinical neuropathy
- Prior platinum or antitubulin agents allowed provided patient has no clinical neuropathy
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
Where it is running
- Montefiore Medical Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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