Status:
COMPLETED
Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cel...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with loc...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Diagnosis based on the primary lesion and/or lymph nodes
- Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
- No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
- No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks
- PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 9.0 g/dL (transfusion or other intervention to achieve hemoglobin \> 8.0 g/dL allowed)
- Bilirubin ≤ 1.5 mg/dL
- AST, ALT, and AP ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
- None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:
- Calcium \< 7 mg/dL or \> 12.5 mg/dL
- Glucose \< 40 mg/dL or \> 250 mg/dL
- Magnesium \< 0.9 mg/dL or \> 3 mg/dL
- Potassium \< 3 mmol/L or \> 6 mmol/L
- Sodium \< 130 mmol/L or \> 155 mmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
- No prior allergic reaction to study drugs
- No active cardiac disease, defined as any of the following:
- Unstable angina
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
- Uncontrolled arrhythmia
- Congestive heart failure
- Three or more heart-related hospitalizations within the past year
- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
- No AIDS
- No pre-existing peripheral sensory neuropathy ≥ grade 2
- No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival
- PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy for this cancer
- Prior systemic chemotherapy for a different cancer allowed
- No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
- At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim \[G-CSF\]) during radiotherapy
- No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00851877
Start Date
March 1 2009
End Date
August 3 2015
Last Update
August 21 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Research Institute
Dallas, Texas, United States, 75204
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75239