Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer
Completed · Phase 2
Conditions studied: Recurrent Nasopharyngeal Cancer, Stage IV Nasopharyngeal Cancer
In brief
This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine may kill more tumor cells
Key facts
- Study ID
- NCT00305734
- Run by
- National Cancer Institute (NCI)
- People needed
- 50
- Starts
- 2006-08-01
- 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 nasopharyngeal carcinoma (NPC) of one of the following subtypes:
- Non-keratinizing (WHO type II)
- Undifferentiated (WHO type III)
- Disease meets one of the following stage criteria:
- Stage IVC at diagnosis
- Persisted, metastasized, or recurred after definitive surgery, radiotherapy, and/or chemotherapy
- Measurable disease
- If only measurable disease is within a prior radiation therapy port, disease progression must be clearly demonstrated
- No known CNS metastases
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin normal
- SGOT or SGPT ≤ 2.5 times ULN
- Zubrod performance status 0-2
- No peripheral neuropathy > grade 1
- No prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
- More than 6 months since prior myocardial infarction
- No New York Heart Association class III or IV cardiac problems
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No acute ischemia by ECG
- No active conduction system abnormalities
Where it is running
- Southwest Oncology Group — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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