Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer
CompletedPhase 2Results postedLast updated 24 September 2024
What this trial tests
Phase 2 trial testing paclitaxel albumin-stabilized nanoparticle formulation in Human Papilloma Virus Infection in 62 participants. Completed in 6 September 2024.
18 and older, any sex, with Human Papilloma Virus Infection or Stage III Squamous Cell Carcinoma of the Oropharynx. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS), Evaluated Using RECIST Version (v) 1.1Primary· Time from enrollment until disease progression or death from any cause, assessed at 2 years
If all patients are followed for two years, the PFS rate and confidence interval will be determined based on the exact binomial distribution. Otherwise, PFS will be estimated using the Kaplan-Meier method and a (large-sample) one-sided 90% confidence interval will be derived for the PFS rate at two years to test the non-inferiority hypothesis. Median PFS will be estimated as described in Brookmeyer and Crowley.
Group
Value
95% CI
Single Arm
94.5
88 – 96
Rate of Pathologic Complete Response (PCR) on Post Treatment Biopsy/Surgery, Evaluated Using RECIST v1.1Secondary· Up to 8 weeks after completion of CRT
Pathologic response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
Group
Value
95% CI
Single Arm
90
79 – 97
Clinical Complete Response by Computerized Tomography (CT) & Magnetic Resonance Imaging (MRI) OnlySecondary· Up to 5 years
Clinical response rates will be determined and 95% confidence intervals obtained using the exact binomial distribution.
complete response
Group
Value
95% CI
Single Arm
13
5.8 – 24
Partial Response
Group
Value
95% CI
Single Arm
80
68 – 89
Stable Disease
Group
Value
95% CI
Single Arm
13
5.8 – 24
Overall SurvivalSecondary· From the date of registration to the date of death or date of last patient contact if censored, assessed up to 5 years
Overall survival rate
Group
Value
95% CI
Single Arm
87
66 – 95
Cancer-specific SurvivalSecondary· Up to 5 years
Overall Cancer-specific survival rate. Patients dying from non-cancer related causes will be censored at the time of death.
Group
Value
95% CI
Single Arm
95
85 – 98
Rates of Acute Toxicity, Determined by Incidence of Mucositis, Xerostomia, Anorexia, Weight Loss, Dermatitis and G-tube PlacementSecondary· Up to 5 years
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of acute (mucositis, xerostomia, anorexia, weight loss, dermatitis and G-tube placement) toxicities will be estimated along with 95% confidence intervals. Toxicity criteria of the Common Toxicity Criteria (CTC) and the Radiation Therapy Oncology Group (RTOG) will be used to determine grades. General CTC grade definitions: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse e
Grade 3+ mucositis
Group
Value
95% CI
Single Arm
35
Grade 3+ dermatitis
Group
Value
95% CI
Single Arm
12
grade 3+ neutropenia
Group
Value
95% CI
Single Arm
29
grade 3+ Anorexia
Group
Value
95% CI
Single Arm
5
Rates of Late Toxicity, Determined by Incidence of Xerostomia, Dental Decay, Osteroradionecrosis, G-tube Dependency, Tracheostomy Placement and DysphagiaSecondary· Up to 5 years
Toxicity rates will be summarized by type of toxicity, grade, and attribution. The incidence of late-term (xerostomia, dental decay, osteroradionecrosis, G-tube dependency, speech abnormalities, tracheostomy placement and dysphagia) toxicities will be estimated along with 95% confidence intervals.
G-tube dependence
Group
Value
95% CI
Single Arm
18
Dysphagia
Group
Value
95% CI
Single Arm
18
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 24 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02258659.