Trials / Completed

CompletedNCT02258659

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

An Exploratory Pilot Study of Nab-paclitaxel Based Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Patients With Stage III and IV HPV-Related Oropharyngeal Cancer - the OPTIMA HPV Trial

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 62 (actual)

Sponsor: University of Chicago · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the 2-year progression-free survival (PFS). SECONDARY OBJECTIVES: I. Clinical complete response rate (nab-paclitaxel based induction, compared to European Prospective Investigation into Cancer and Nutrition \[EPIC\] induction \[paclitaxel based\]). II. Response rate (nab-paclitaxel based induction, compared to EPIC induction \[paclitaxel based\]). III. Proportion of patients with \>= 50% shrinkage by Response Evaluation Criteria In Solid Tumors (RECIST) (nab-paclitaxel based induction, compared to EPIC induction, paclitaxel based). IV. Toxicity (nab-paclitaxel based induction, compared to EPIC induction \[paclitaxel based\]). V. To assess swallowing function and speech at 6 months (mos) and 12 mos post therapy. VI. To determine the rates of late toxicity with chemoradiation following surgery as determined by xerostomia, dental decay, osteroradionecrosis, G-tube dependency, tracheostomy placement and dysphagia. VII. 2-year overall survival (OS) in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms. VIII. 2-year PFS in patients treated on the Low-Risk, Intermediate-Risk Arm, and High-Risk Arms - early and late toxicities. IX. Evaluate need for post radiotherapy/chemoradiotherapy (RT/CRT) surgery on low- and intermediate-risk arms based on response from induction chemotherapy. X. Evaluate in a descriptive manner the role of transoral robotic surgery (TORS) resection/lymph node dissection (LND) when integrated into a de-escalation trial. TERTIARY OBJECTIVES: I. To evaluate pathologic/histologic appearance of tumor after induction chemotherapy and after CRT. II. Translational research on blood and tissue samples. III. To profile tumors genetically and immunologically in order to assess in a descriptive manner genetic or immunological features characteristic of clinical behavior. OUTLINE: INDUCTION CHEMOTHERAPY: All patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are then assigned to 1 of 3 treatment groups based on response to induction chemotherapy. GROUP A (LOW-DOSE ARM): Patients undergo radiation therapy once daily for 5 weeks. GROUP B (INTERMEDIATE-DOSE ARM): Patients receive hydroxyurea orally (PO) twice daily (BID) on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive low-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. GROUP C (STANDARD-DOSE ARM): Patients receive hydroxyurea PO BID on days 0-5, fluorouracil IV continuously on days 1-5, and paclitaxel IV over 60 minutes on day 1. Patients also receive standard-dose radiation therapy BID on days 1-5. Treatment repeats every 14 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.\* \*NOTE: At the discretion of the principal investigator (PI), patients may receive cisplatin IV over 1-3 hours every 3 weeks during radiation therapy instead of paclitaxel and undergo daily radiation therapy. After completion of study treatment, patients are followed up for 30 days, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

Conditions

Interventions

Type	Name	Description
DRUG	paclitaxel albumin-stabilized nanoparticle formulation	Given IV
DRUG	carboplatin	Given IV
RADIATION	radiation therapy	Undergo radiation therapy
DRUG	paclitaxel	Given IV
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

Timeline

Start date: 2014-09-22
Primary completion: 2024-09-06
Completion: 2024-09-06
First posted: 2014-10-07
Last updated: 2024-09-24
Results posted: 2021-01-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02258659. Inclusion in this directory is not an endorsement.