Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)

NCT00904345 | Terminated Phase 2 Results DMC

• 2 other identifiers: UMCC 2009.009HUM 27253
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.

Conditions

Head and Neck Cancer

Keywords

SCC Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)

  The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.

  At baseline (pre-loading dose) and day 7 post-loading dose

• Mean Change in Tumor Phosphorylated EGFR (pEGFR)

  The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.

  At baseline (pre-loading dose) and day 7 post-loading dose

• Progression Free Survival Rate

  Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.

  At 1 and 2 years

• Overall Survival Rate

  Percentage of participants alive at 1 and 2 years after enrollment.

  At 1 and 2 Years

• Number of Participants With Treatment Related Toxicities

  Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.

  3 years

Secondary Outcomes (2)

• Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa

  At baseline (pre-loading dose) and day 7 post-loading dose

• Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa

  At baseline (pre-loading dose) and day 7 post-loading dose

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Cetuximab; Radiation: 50-60 Gy and 70 Gy

Interventions

Cetuximab DRUG

Patients will receive a single dose of cetuximab 400 mg/m (Day 0). On day 7 (+/- 1 day), a repeat biopsy will be performed. Radiation concurrent with weekly cetuximab 250 mg/m.

Treatment

50-60 Gy and 70 Gy RADIATION

Within approximately 4 days (after single dose of Cetuximab), definitive radiation will begin (70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes) concurrent with weekly cetuximab 250 mg/m.

Treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
• Patients will be limited to:
• ≥ 70 years of age, OR
• with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
• KPS ≤ 80, OR
• Creatinine clearance \< 30 cc/min
• Laboratory criteria:
• WBC \> 3500/ul
• Granulocyte \> 1500/ul
• Platelet count \> 100,000/ul
• Total Bilirubin \< 1.5 X ULN
• AST and ALT \< 2.5 X ULN
• Patients must give documented informed consent to participate in this study.

You may not qualify if:

• Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
• Prior head and neck radiation or chemotherapy.
• Documented evidence of distant metastases.
• Patients with nasopharyngeal carcinoma.
• Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
• Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
• Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
• Patients residing in prison.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (2)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Veterans Administration Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Shruti Jolly, M.D.
• Organization: University of Michigan Rogel Cancer Center

shrutij@med.umich.edu

734-936-4302

Study Officials

• Shruti Jolly, MD

  University of Michigan Rogel 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: SPONSOR

Study Record Dates

• First Submitted: May 17, 2009
• First Posted: May 19, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 24, 2021
• Results First Posted: January 20, 2021

Record last verified: 2021-02

Locations

US (2)