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Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab

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ClinicalTrials.gov Identifier: NCT00319839
Recruitment Status : Terminated (slow accrual)
First Posted : April 27, 2006
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sai-Hong Ignatius Ou, University of California, Irvine

Brief Summary:

Primary Objective: To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer with the addition of Cetuximab on disease progression.

Approximately 40,000 new cases of head and neck cancer are diagnosed annually in the United States (Jemal et al, 2003), and over 30% of these patients are expected to die of their malignancy. Squamous cell carcinoma accounts for more than 90% of head and neck cancer cases. Although metastatic disease at the time of diagnosis is rather uncommon, and despite aggressive use of up-front concurrent radiation and cisplatin-based chemotherapy, approximately 20% of the patients will develop metastases. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis

A subsequent randomized study conducted by ECOG (E1393) compared high-dose paclitaxel (200 mg/m2) as a 24-hour infusion plus cisplatin 75 mg/m2 with G-CSF support, to low dose paclitaxel (135 mg/m2) as a 24-hour infusion, plus cisplatin 75 mg/m2 (Forastiere et al, 2001). Patients with newly diagnosed metastatic or recurrent squamous cell carcinoma of the head and neck, excluding nasopharyngeal primaries were eligible. No prior treatment for recurrent/metastatic disease was allowed, but patients could have received chemotherapy as a part of the initial curative therapy that should have been completed 6 months prior to study.

No statistically significant difference could be demonstrated either in response rates or survival between the two arms (Murphy et al, 2001). This study, however, indicated that paclitaxel, a member of the taxane class of anti-tumor agent, is active in head and neck cancer.

New agents to treat head and neck cancer need to be investigated. Abraxane, an albumin-bound formulation of paclitaxel has shown significant single-agent activity in breast cancer and in head and neck cancer. Recently, Abraxane has approved for use in metastatic breast cancer. Given previous randomized phase III trials indicated single agent chemotherapy fared as well as combination chemotherapy regimen in terms of overall survival, this novel formulation should be actively investigated in head and neck cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Abraxane Drug: Cetuximab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Albumin Bound-Paclitaxel (AbraxaneTM) for Treatment of Recurrent or Metastatic Head and Neck Cancer With the Addition of Cetuximab (Erbitux) (IMC-225) on Disease Progression
Study Start Date : March 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Abraxane plus Cetuximab
Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
Drug: Abraxane
260 mg/m2 IV over 30 minutes every 3 weeks
Other Names:
  • Albumin-bound Paclitaxel
  • ABI-007
Drug: Cetuximab
Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles
Other Names:
  • IMC-225
  • Erbitux
  • NSC-714692



Primary Outcome Measures :
  1. Overall Response Rate (Complete and Partial Response) [ Time Frame: 3 years ]
    To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.


Secondary Outcome Measures :
  1. Frequency and Severity of Toxicities [ Time Frame: 3 years ]
    To assess the frequency and severity of toxicities associated with this treatment.

  2. Overall Survival and Progression-free Survival in Patients [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must have histologically or cytologically confirmed carcinoma of the head and neck region. Primary tumor sites include: lip and oral cavity, major salivary glands, pharynx (oropharynx, nasopharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis), nasal cavity and paranasal sinuses, and thyroid
  • Patients must have metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy.
  • All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable and non-measurable disease must be assessed within 28 days prior to registration.
  • Patients may have prior chemotherapy for recurrent/metastatic disease. However, all chemotherapy must be completed at least 21 days prior to scheduled start of Abraxane.
  • Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) > 1,500 μl and platelets > 100,000/ μl obtained within 14 days prior to registration.
  • Patients must have adequate hepatic as documented by serum bilirubin < 1.5 x the institutional upper limit of normal. These tests must be obtained within 14 days prior to registration.
  • All patients must be 18 years of age or older
  • Patients must have a Zubrod performance of 0-3

Exclusion Criteria:

  • Patients must not have prior therapy with Abraxane
  • Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible.
  • Patients with baseline grade 3 peripheral neuropathy are not eligible.
  • Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for eligibility if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease.

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): NCT00319839


Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: S.-H. Ignatius Ou, MD, PhD Chao Family Comprehensive Cancer Center

Responsible Party: Sai-Hong Ignatius Ou, HS Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00319839     History of Changes
Other Study ID Numbers: UCI 05-46
2005-4667 ( Other Identifier: University of California, Irvine )
First Posted: April 27, 2006    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Sai-Hong Ignatius Ou, University of California, Irvine:
Head cancer
Neck cancer
cetuximab
abraxane
erbitux
IMC-225
NSC-714692

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action