We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847326
Recruitment Status : Active, not recruiting
First Posted : May 6, 2013
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Salivary Gland Squamous Cell Carcinoma Tongue Cancer Drug: carboplatin Drug: paclitaxel albumin-stabilized nanoparticle formulation Drug: fluorouracil Drug: hydroxyurea Procedure: therapeutic conventional surgery Radiation: radiation therapy Radiation: hyperfractionated radiation therapy Other: laboratory biomarker analysis Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in combination with FHX (5 fluorouracil [fluorouracil], hydroxyurea and twice daily radiation, in good induction responders) and of nab-paclitaxel added to hypofractionated radiotherapy for poor responders.

II. To explore the feasibility of a more rapid palliative chemoradiotherapy approach inpatients with refractory disease as demonstrated by failure to respond to initial chemotherapy.

III. To explore the role of induction chemotherapy as a predictive tool for definitive head and neck cancer management of previously treated patients.

SECONDARY OBJECTIVES:

I. Progression-free survival (PFS) (time to disease progression or death from any cause) on both study arms.

II. Overall survival and response rates in both arms.

TERTIARY OBJECTIVES:

I. To determine the correlation of secreted protein, acidic, cysteine-rich (SPARC) expression in head and neck cancer and response to therapy.

OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation.

RE-INDUCTION THERAPY (WEEKS 1-6): Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving good response undergo surgical resection and proceed to chemoradiation within 4-6 weeks.

AFHX REGIMEN: Patients achieving response to re-induction therapy receive hydroxyurea orally (PO) every 12 hours for 6 days (11 doses) beginning on day 0, fluorouracil IV continuously over 120 hours beginning on day 0, and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Patients also undergo radiation therapy twice daily (BID) on days 1-5. Courses repeat every 14 days for 5 weeks in the absence of disease progression or unacceptable toxicity.

PACLITAXEL + RADIATION (AXX) REGIMEN: Patients not achieving response to re-induction therapy receive paclitaxel albumin-stabilized nanoparticle formulation IV and undergo hypofractionated radiation therapy on day 1. Courses repeat every 7 days for 5 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 2 years, every 6 months for 2 years, and then yearly thereafter.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.
Actual Study Start Date : March 26, 2013
Actual Primary Completion Date : May 4, 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment (induction therapy and AFHX or AXX)
See Detailed Description
 Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
Other Names:
  • ABI-007
  • nab paclitaxel
  • nab-paclitaxel
  • nanoparticle albumin-bound paclitaxel

Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU

Drug: hydroxyurea
Given PO
Other Names:
  • HU
  • HYD
  • Hydrea
  • Hydroxycarbamide
  • Hydurea

Procedure: therapeutic conventional surgery
Undergo surgical resection

Radiation: radiation therapy
Undergo radiation therapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation

Radiation: hyperfractionated radiation therapy
Undergo hyperfractionated radiation therapy

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0 [ Time Frame: 4 weeks ]
  2. Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. PFS [ Time Frame: The time from the date of registration to the date of progressive disease or death, assessed up to 1 year ]
    Statistical significance will be determined by a two-sided P value =< 0.05. Progression-free survival curves will be calculated using the Kaplan-Meier method, and median progression-free survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley.

  2. Overall survival [ Time Frame: The time from the date of registration to the date of death, assessed up to 1 year ]
    Statistical significance will be determined by a two-sided P value =< 0.05. Overall survival curves will be calculated using the Kaplan-Meier method, and median overall survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley.

  3. Objective response rate (complete response [CR] + partial response [PR]) [ Time Frame: Up to 1 year ]
    The objective response rate (CR + PR) and associated 90% confidence interval will be determined.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
  • Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847326


Locations
Layout table for location information
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Jonas de Souza University of Chicago Comprehensive Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01847326    
Other Study ID Numbers: 12-1554
NCI-2012-02179 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: July 13, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Carcinoma, Verrucous
Squamous Cell Carcinoma of Head and Neck
Salivary Gland Neoplasms
Nasopharyngeal Carcinoma
Tongue Neoplasms
Laryngeal Diseases
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
 Neoplasms, Squamous Cell
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Respiratory Tract Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases