Status:
COMPLETED
Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs u...
Detailed Description
OBJECTIVES: Primary * Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with bortezomib and docetaxel. Secondary ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- Recurrent or metastatic disease
- Measurable disease
- Not a candidate for curative therapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm³
- AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
- AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- Bilirubin normal
- Creatinine clearance ≤ 2.0 mg/dL
- No peripheral neuropathy ≥ grade 2 within the past 28 days
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart failure
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- No known hypersensitivity to bortezomib, boron, or mannitol
- No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No serious medical or psychiatric illness that would preclude study participation
- No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for recurrent or metastatic disease
- At least 28 days since prior and no other concurrent investigational drugs
- No other concurrent anticancer therapy
- No other concurrent chemotherapy
- No concurrent complementary or herbal medicine
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00425750
Start Date
August 1 2005
End Date
June 1 2009
Last Update
November 16 2011
Active Locations (7)
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1
Jennie Stuart Medical Center
Hopkinsville, Kentucky, United States, 42240-2400
2
Purchase Cancer Group - Paducah
Paducah, Kentucky, United States, 42001
3
Tennessee Plateau Oncology - Crossville
Crossville, Tennessee, United States, 38555
4
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301