Status:
COMPLETED
Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in combination...
Eligibility Criteria
Inclusion
- Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
- Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
- Prior radiation therapy completed \>= 4 months, and/or chemotherapy completed \>= 1 month before study entry, and patient should have recovered from any adverse effects
- Predominance of disease that is amenable to radiotherapy
- Measurable disease prior to induction chemotherapy
- Eastern Cooperative Oncology Group performance status of one or less
- Life expectancy of greater than 12 weeks
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
- Patients must have \< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events \[CTCAE\])
- Leukocyte \>= 3,000/ul
- Absolute neutrophil count \>= 1,500/ul
- Platelets \>= 1000,000/ul
- Total bilirubin =\< 1.5 x institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x institutional upper limit of normal
- Creatinine clearance (CrCl) \> 45 mL/min
Exclusion
- Previously untreated patients with locoregional-only disease are not eligible
- Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
- Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
- Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
March 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01847326
Start Date
March 26 2013
End Date
January 22 2024
Last Update
July 31 2024
Active Locations (1)
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1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470