CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
paclitaxel albumin-stabilized nanoparticle formulation +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02258659
NCT02258659Phase 2Completed

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

University of Chicago·interventional·Posted Oct 7, 2014·Updated Sep 24, 2024

In Brief

A Phase 2 clinical trial evaluating paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, and 7 other interventions for Human Papilloma Virus Infection and 3 related conditions. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartSep 22, 2014
Primary CompletionSep 6, 2024
TodayJul 2, 2026
Enrollment to primary: 10.0 yearsPosted 11.7 years ago

Interventions

paclitaxel albumin-stabilized nanoparticle formulationdrug

Given IV

carboplatindrug

Given IV

radiation therapyradiation

Undergo radiation therapy

paclitaxeldrug

Given IV

fluorouracildrug

Given IV

hydroxyureadrug

Given PO

cisplatindrug

Given IV

laboratory biomarker analysisother

Correlative studies

quality-of-life assessmentprocedure

Ancillary studies