Phase 2 N=62 Treatment

Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer

Human Papilloma Virus Infection · Stage III Squamous Cell Carcinoma of the Oropharynx · Stage IVA Squamous Cell Carcinoma of the Oropharynx · Stage IVB Squamous Cell Carcinoma of the Oropharynx

Bottom Line

View on ClinicalTrials.gov: NCT02258659 ↗

Enrolled (actual)

Serious AEs

8.1%

Results posted

Jan 2021

Primary outcome: Primary: Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1 — 94.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: paclitaxel albumin-stabilized nanoparticle formulation (Drug); carboplatin (Drug); radiation therapy (Radiation); paclitaxel (Drug); fluorouracil (Drug); hydroxyurea (Drug); cisplatin (Drug); laboratory biomarker analysis (Other); quality-of-life assessment (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1	94.5	—
SECONDARY Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1	90	—
SECONDARY Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) Only	13; 80; 13	—
SECONDARY Overall Survival	87	—
SECONDARY Cancer-specific Survival	95	—
SECONDARY Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube Placement	35; 12; 29; 5	—
SECONDARY Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and Dysphagia	18; 18	—

Summary

This phase II trial studies nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) and carboplatin followed by response-based local therapy in treating patients with stage III or IV human papillomavirus (HPV)-related oropharyngeal cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, hydroxyurea, fluorouracil, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Radiation therapy uses high energy x rays to kill tumor cells. Giving nab-paclitaxel and carboplatin before chemoradiation may make the tumor smaller and reduce the amount of chemotherapy and radiation therapy needed. Assigning chemotherapy and radiation therapy based on response (response-based therapy) and giving patients who are responding well lower doses of treatment may help reduce the occurrence of side effects.

Eligibility Criteria

Inclusion Criteria

Patients must have pathologically confirmed HPV-positive squamous cell carcinoma
HPV testing must follow the following criteria
HPV testing using an E6/E7 based assay is preferred, and does not require any validation (e.g. HPV in situ hybridization [ISH] or HPV E6/E7 polymerase chain reaction [PCR])
For oropharyngeal tumors p16 immunohistochemistry (IHC) positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan/Lingen et al 2012); it is recommended that p16 IHC positivity is validated at a later point (during or after treatment) using an E6/E7 based test at the University of Chicago and provided slides will be used
For non-operative (OP) tumors accurate HPV testing (i.e. ISH, or E6/E7 based testing) is required for enrollment and treatment initiation
Availability of >= 10 unstained 5 micron slides
Patients with American Joint Committee on Cancer (AJCC) (7th edition, 2010) nodal stage N2 or N3 or a T4 primary tumor
The primary and nodal involvement must be assessable on clinical exam (mucosal and lymph node exam)
The primary and nodal involvement must have been defined bi- or uni-dimensional measurements measurable by RECIST
No previous radiation or chemotherapy for a head and neck cancer
No surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy of the tumor is acceptable)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)
Leukocytes >= 3000/mm^3
Platelets >= 100,000/mm^3
Absolute neutrophil count >= 1,500
Hemoglobin > 9.0 gm/dL
Albumin > 2.9 gm/dL
Total bilirubin = 45 mL/min (or serum creatinine [SCr] = = grade 1

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02258659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.