Status:
TERMINATED
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...
Detailed Description
OBJECTIVES: Primary * Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and f...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage IVA or IVB disease
- Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
- Measurable or evaluable disease
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
- Bilirubin normal
- Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Exclusion
- Salivary gland, sinus, or nasopharyngeal primary disease
- Evidence of distant metastatic disease
- Pregnant or nursing
- Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
- Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
- Peripheral neuropathy ≥ grade 2
- Hearing loss ≥ grade 2
- Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
- Poor nutritional status, in the opinion of the investigator
- Active infection
- Active ischemic heart disease
- Myocardial infarction within the past 6 months
- Prior radiotherapy above the clavicles
- Prior chemotherapy
- Prior surgery to the primary tumor except biopsy
- Concurrent amifostine or other investigational agents
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00352118
Start Date
March 1 2006
End Date
April 1 2008
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455