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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of California, Irvine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00319839
First received: April 27, 2006
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: Abraxane
Drug: Centuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: UCI 05-46:A Phase II Study of AlbuminBound-Paclitaxel (AbraxaneTM) for Treatment of Recurrent or Metastatic Head and Neck Cancer With the Addition of Cetuximab (Erbitux) (IMC-225) on Disease Progression

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To assess the overall response rate (complete and partial response) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the frequency and severity of toxicities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To evaluate overall survival and progression-free survival in patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess whether the addition of Cetuximab will re-sensitize head and neck cancer to Abraxane after progression on single agent Abraxane. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Abraxane
    260 mg/m2 IV over 30 minutes every 3 weeks
    Other Names:
    • Albumin-bound Paclitaxel
    • ABI-007
    Drug: Centuximab
    Centuximab 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
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each of the criteria in the following section must be met in order for a patient to be eligible for registration.
  • Patients should have hemoglobin > 9 g/dL; patients may be transfused to achieve this level of hemoglobin.
  • Alkaline phosphatase. Normal [26-110] IU/L
  • Bone scan, if clinically indicated. < 2 x institutional upper limit of normal.
  • Patients should not have known AIDS or HIV-1 associated complex or known history of immune or immunodeficiency disorders because of unknown or potential interactions of anti-retroviral therapy with Abraxane. Additionally, the severely depressed immune system found in HIV-infected patients and the possibility or premature death would compromise study objectives.
  • Patients should not have active infection.
  • Patients should not have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with study protocol.
  • Patients should not have any immediate life-threatening complications of their malignancies.
  • 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 ANC >=1,500 ul and platelets > 100,000/ ul 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.
  • Patients must not have prior therapy with Abraxane; this will enable the researchers to assess the patient response rate in patients that have not been treated with Abraxane. If any patient has been treated with Abraxane outside of this study and they are responding the patient would probably continue to be treated as such in their best interest. Patients who have been treated with other taxanes (not Abraxane) previously, can still respond to this new formulation.
  • Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible. Potential subjects will be screened for any pre-existing heart conditions.
  • 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.
  • Patients who are pregnant are not eligible. There is not enough medical information to know what the risks might be to a breast-fed infant or to an unborn child carried by a mother who is taking part in the study. If patient is of childbearing age, sexual partner and the patient must use proven birth control measures while on the study. Effective methods of contraception are oral contraceptives, diaphragm, condom, contraceptive foam or male/female sterilization. If the patient is breast-feeding, they must stop breast-feeding. If the patient is still having period and can become pregnant, a pregnancy test must be done before taking part in the study. The pregnancy test must be taken 7 days prior to taking part in the study. If the pregnancy test is positive, the patient will not be able to take part in the study.
  • Sample size justification: On average about 75 head and neck cancer patients are treated at UCI annually. One third of these patients will eventually require and receive chemotherapy for the study disease. Therefore an accrual period of 2 years is expected to accrue a total of 44 patients.
  • It is assumed that the Abraxane therapy will be of no further interest if the true confirmed response rate is < 5%, but will warrant further study if the response rate is > 20%. Utilizing a two-stage design and statistical tools from the Southwest Oncology Group (SWOG) [http://www.swogstat.org/statoolsout.html] and assuming a power of 90% and a significance level of 5% for sample size calculation, for the first stage of the study, a total of 20 eligible patients will be enrolled. The trial will proceed to the second stage if at least 1 patient achieves a partial or complete response to Abraxane. Given an estimated 10% drop-out rate, 22 patients will be enrolled at stage 1 and 22 patients will be enrolled in stage 2 for a total number of 44 patients enrolled. If a total of at least 5 patients achieve a partial or complete response to Abraxane, the regimen will be considered as worthy of further study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sai-Hong Ignatius Ou, MD, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00319839     History of Changes
Other Study ID Numbers: UCI 05-46
Study First Received: April 27, 2006
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Head cancer
Neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Cetuximab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014