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

NCT00319839 | Terminated Phase 2 Results DMC

• 2 other identifiers: UCI 05-462005-4667
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head cancer; Neck cancer; cetuximab; abraxane; erbitux; IMC-225; NSC-714692

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete and Partial Response)

  To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.

  3 years

Secondary Outcomes (2)

• Frequency and Severity of Toxicities

  3 years

• Overall Survival and Progression-free Survival in Patients

  3 years

Study Arms (1)

Abraxane plus Cetuximab

EXPERIMENTAL

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; Drug: Cetuximab

Interventions

Abraxane DRUG

260 mg/m2 IV over 30 minutes every 3 weeks

Also known as: Albumin-bound Paclitaxel, ABI-007

Abraxane plus Cetuximab

Cetuximab 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

Also known as: IMC-225, Erbitux, NSC-714692

Abraxane plus Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Albumin-Bound Paclitaxel; Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Chao Family Comprehensive Cancer Center
• Organization: University of California, Irvine

UCstudy@uci.edu

(877) 827-8839

Study Officials

• S.-H. Ignatius Ou, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HS Clinical Professor

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 12, 2018
• Results First Posted: January 12, 2018

Record last verified: 2018-01

Locations

US (1)