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Head and Neck CancerPhase 2NCT00096174

Phase II Study of Concurrent C225, Cisplatin and Radiation in Stage IV Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing cetuximab C225, cisplatin and radiation therapy in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
cetuximab C225, cisplatin and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
No sites listed yet
Study dates
8 Apr 2005to Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck (excluding nasopharynx, paranasal sinus, and parotid gland)
  • Unresectable locally advanced or regional stage IV disease
  • No evidence of distant metastases
  • Must have demonstrable primary tumor site
  • Measurable disease
  • Unresectable disease
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  • Meets the following criteria for unresectable disease by tumor site:
  • Hypopharynx, meeting 1 of the following criteria:
  • Extension across the midline of the posterior pharyngeal wall
  • Any evidence of fixation to the cervical spine
  • Larynx
  • Direct subglottic extension (>3cm) into surrounding muscle or skin
  • Oral cavity
  • Lesion precluding functional reconstruction
  • Base of tongue, meeting 1 of the following criteria:
  • Extension into the root of the tongue
  • Patient refuses total glossectomy
  • Tonsillar area, meeting 1 of the following criteria:
  • Extension into pterygoid area as manifested by x-ray or trismus
  • Extension across midline of pharyngeal wall
  • Direct extension into soft tissue of the neck
  • Unilateral neck node metastases fixed to carotid artery, mastoid, base of skull, or cervical spine with any of the above tumors
  • Patients requiring total glossectomy are eligible
  • Age>=18 years
  • ECOG Performance status of 0-1
  • Adequate hematologic, renal, and hepatic function obtained <=4 weeks prior to registration
  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Alkaline phosphatase ≤ 3 times normal
  • Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 3 times normal
  • Bilirubin ≤ 1.5 mg/dL
  • Creatinine ≤ 1.2 mg/dL OR creatinine clearance ≥ 50 mL/min
  • Able to tolerate fluid load
  • At least 14 days since major surgery (including dental extraction) except percutaneous endoscopic gastrostomy (PEG) placement or mediport placement

Who cannot join

  • Pregnant or nursing
  • Fertile patients do not use effective contraception
  • Patients who refuse surgery but whose tumors are technically resectable OR whose tumors are unresectable for medical reasons are not eligible
  • Disease metastases below the clavicles or elsewhere (M1) or with a postoperative recurrence
  • Prior excisional surgery of head and neck tumor
  • Prior radiotherapy to the head and neck region
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  • Prior chemotherapy
  • Prior drugs that target the epidermal growth factor receptor pathway
  • Prior chimerized or murine monoclonal antibody
  • Active systemic infection
  • Known allergy to murine proteins
  • Severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • Myocardial infarction within the past 3 months
  • Uncontrolled congestive heart failure
  • Unstable or uncontrolled angina
  • Clinically apparent jaundice
  • Postoperative recurrence
  • Other malignancy within the past 3 years except resected basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ tumors

About this study

Official title: Phase II Study of C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cetuximab may make the tumor cells more sensitive to radiation therapy and chemotherapy. Giving monoclonal antibody therapy together with chemoradiotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with locally advanced or regional stage IV head and neck cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine 2-year progression-free survival in patients with unresectable locally advanced or regional stage IV squamous cell or undifferentiated carcinoma of the head and neck treated with cetuximab, cisplatin, and definitive radiotherapy.

Secondary

  • Determine response rate and overall survival in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Correlate epidermal growth factor receptor (EGFR) expression by immunohistochemistry, EGFR phosphorylation, map kinase, Akt, signal transducer and activator of transcription 3 (STAT3), and other tissue and serum tests with toxicity of this regimen and outcomes in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor site (hypopharynx vs. oropharynx vs. oral cavity vs. larynx), primary tumor stage (T1-3 vs. T4), and nodal status (N0 vs. N1 vs. N2-3).

  • Cetuximab therapy: Patients receive an initial loading dose of cetuximab IV over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.
  • Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.
  • Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 10 years.

ACCRUAL: A total of 69 patients were accrued for this study.

Being tested
cetuximab C225, cisplatin, radiation therapy
Keywords
stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximab C225Biological

    Also called Cetuximab, Erbitux

    400 mg/m^2 IV over 120 minutes on Day 1, 250 mg/m^2 IV over 60 minutes on Day 8, then weekly

  • cisplatinDrug

    Also called Platinol, Platinol-AQ, CDDP, DDP

    75 mg/m^2 IV over 30-60 minutes starting day 15 every 3 weeks * 3 (Days 1, 22, and 43 of radiation therapy (RT))

  • radiation therapyRadiation

    RT 70 Gy / 35 starting Day 15, 200cGy / d * 7 weeks (35 fractions)

Study groups in NCT00096174
Study groupRoleWhat they receive
Cisplatin, C225, RadiationExperimental* Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57. * Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57. * Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
Receives: Biological: cetuximab C225; Drug: cisplatin; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year Progression-free Survival Rate

    Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.

    Measured: assessed every 3 months for 2 years

Secondary outcomes (2)

  1. 2-year Overall Survival Rate

    Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.

    Measured: assessed very 3 months for 2 years

  2. Overall Response Rate

    Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients

    Measured: assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study start8 Apr 2005
  3. Primary completionJul 2009
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096174
Sponsor's protocol ID
CDR0000390923
Other IDs
U10CA021115, E3303
Status last verified
Jun 2023
First submitted
9 Nov 2004
Last updated
29 Jun 2023
Data monitoring committee
No

Publications

  • Langer CJ, Lee JW, Patel UA, et al.: Preliminary analysis of ECOG 3303: concurrent radiation (RT), cisplatin (DDP) and cetuximab (C) in unresectable, locally advanced (LA) squamous cell carcinoma of the head and neck (SCCHN). [Abstract] J Clin Oncol 26 (Suppl 15): A-6006, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab C225, cisplatin and radiation therapy in people with Head and Neck Cancer, run by Eastern Cooperative Oncology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Progression-free Survival Rate (time frame: assessed every 3 months for 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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