Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 used in chemotherapy, such as docetaxel, 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 docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Docetaxel

Criteria

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)