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

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.

Conditions

• 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

Interventions

DRUG

fluorouracil

Given IV

DRUG

hydroxyurea

Given PO

DRUG

cisplatin

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

PROCEDURE

quality-of-life assessment

Ancillary studies

DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Given IV

DRUG

carboplatin

Given IV

RADIATION

radiation therapy

Undergo radiation therapy

DRUG

paclitaxel

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Chicago

  lead OTHER

Principal Investigators

• Everett Vokes, MD · University of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-22

Primary Completion

2024-09-06

Completion

2024-09-06

Countries

• United States

Study Locations