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NCT01847326CompletedPhase 1

Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer

Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.

Source: ClinicalTrials.gov · Last updated 31 Jul 2024

Brief summary (registry, in English)

This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (actual)
First submitted
19 Apr 2013
Start date
26 Mar 2013
Primary completion date
22 Jan 2024
Lead sponsor
University of Chicago
NCT number
NCT01847326

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 48
  • From 26 Mar 2013 to the primary completion date, 22 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously untreated patients with locoregional-only disease are not eligible
  • Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents

Other illness

  • History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
  • Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Other

  • Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function

Who the study is looking for

  • Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
  • Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
  • Prior radiation therapy completed \>= 4 months, and/or chemotherapy completed \>= 1 month before study entry, and patient should have recovered from any adverse effects
  • Predominance of disease that is amenable to radiotherapy
  • Measurable disease prior to induction chemotherapy
  • Eastern Cooperative Oncology Group performance status of one or less
  • Life expectancy of greater than 12 weeks
  • Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
  • Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
  • Patients must have \< grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events \[CTCAE\])
  • Leukocyte \>= 3,000/ul
  • Absolute neutrophil count \>= 1,500/ul
  • Platelets \>= 1000,000/ul
  • Total bilirubin =\< 1.5 x institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x institutional upper limit of normal
  • Creatinine clearance (CrCl) \> 45 mL/min

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.