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Squamous Cell Carcinoma of the Head and NeckPhase 2NCT00971932

Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

A Phase 2 study testing Cetuximab, Cisplatin/Carboplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 10 sites in Japan.

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

The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Cetuximab, Cisplatin/Carboplatin and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
10 sitesJapan
Study dates
Jul 2009to Mar 2011
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of SCCHN
  • Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
  • Expected survival is more than 6 months
  • Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • Recurrent and/or metastatic SCCHN not suitable for local therapy
  • Greater than or equal to (>=) 20 years of age
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  • Karnofsky performance status (KPS) >= 70% at trial entry
  • Neutrophils: >= 1500 per millimeter^3 (1,500/mm^3); platelet count >= 100,000/mm^3; and hemoglobin >= 9 gram per deciliter (g/dL)
  • Total bilirubin less than or equal to (<=) 2 * upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 * ULN
  • Creatinine clearance >60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
  • Serum calcium within normal range (If serum albumin < 4.0 g/dL, the following adjusted serum calcium concentration should be within normality: Adjusted serum calcium concentration = actual serum calcium (milligram per deciliter [mg/dL]) - 0.8 * [actual serum albumin (g/dL) - 4]
  • Effective contraception if risk of conception exists (applicable for both male and female subjects)
  • Signed written informed consent
  • Japanese (with Japanese citizenship)

Who cannot join

  • Nasopharyngeal carcinoma
  • Prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
  • Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
  • Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin [HCG] test) or breastfeeding
  • Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
  • Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure >= 180 millimeter of mercury [mmHg] and/or diastolic blood pressure >= 130 mmHg under resting conditions) or liver failure
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  • Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
  • Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
  • Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
  • Intake of any investigational medication within 30 days before trial entry
  • Other concomitant anticancer therapies
  • Documented or symptomatic brain or leptomeningeal metastasis
  • Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
  • Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy
  • Legal incapacity or limited legal capacity
  • Other protocol-defined exclusion criteria may apply

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Japan10 sites

  • Research Site

    Aichi

  • National Cancer Center East Hospital

    Chiba

  • Research Site

    Ehime

  • Research Site

    Hokkaido

  • Research Site

    Kanagawa

  • Tokai University

    Kanagawa

  • Research Site

    Osaka

  • Research Site

    Shizuoka

  • Research Site

    Tochigi

  • Research Site

    Tokyo

Other trials in Japan

About this study

Official title: Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects

The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.

Being tested
Cetuximab, Cisplatin/Carboplatin, 5-Fluorouracil
Keywords
Recurrent and/or metastatic, SCCHN
Medical subject headings
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.

  • CetuximabDrug

    The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.

  • Cisplatin/CarboplatinDrug

    Subjects will receive 100 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle. If subject developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) will be administered as an IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.

  • 5-FluorouracilDrug

    Subjects will receive 1000 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle.

Study groups in NCT00971932
Study groupRoleWhat they receive
Cetuximab + Cisplatin/Carboplatin + Fluorouracil (5-FU)ExperimentalNot described
Receives: Drug: Cetuximab; Drug: Cisplatin/Carboplatin; Drug: 5-Fluorouracil

What is being measured

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

  1. Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria

    Percentage of participants experiencing a complete response [CR] (complete disappearance of measurable and evaluable disease without new lesions) or partial response [PR] (greater than or equal to 50 percent decrease in the sum of the products of diameters [SOPD] of index lesions compared to the baseline SOPD, with no evidence of PD) confirmed by a subsequent assessment no less than 28 days after criteria for response were first met based on modified WHO criteria as assessed by Independent Review Committee (IRC).

    Measured: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011

Secondary outcomes (6)

  1. Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

    Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST as assessed by IRC. CR are those that persist on repeat imaging study at least 28 days after initial documentation of response. PR are those with greater than or equal to 30 percent decrease in the SOPD of index lesions compared to the baseline SOPD, with no evidence of PD.

    Measured: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

  2. Disease Control Rate

    Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (>=50 percent decrease in sum of the products of diameters [SOPD] of index lesions compared to baseline SOPD, with no evidence of PD) confirmed by subsequent assessment no less than 28 days after criteria for response were first met) or stable disease [SD] (neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD) at least once no less than 42 days after first dose of trial treatment based on modified WHO criteria as assessed by IRC.

    Measured: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011

  3. Duration of Response

    Duration of response according to modified WHO criteria as assessed by IRC was defined as the time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death when death occurred within 60 days of the last tumor assessment or first administration of trial treatment (whichever was last).

    Measured: Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

  4. Progression-Free Survival (PFS) Time

    The PFS time according to modified WHO criteria as assessed by IRC was defined as duration from first administration of trial treatment until PD (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.

    Measured: Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

  5. Overall Survival (OS) Time

    Time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

    Measured: Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011

  6. Time to Treatment Failure

    Time to treatment failure according to modified WHO criteria as assessed by IRC was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: PD assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment.

    Measured: Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011

Timeline

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

  1. First posted4 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionMar 2011

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
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00971932
Sponsor's protocol ID
EMR 62241-056
Status last verified
Mar 2014
First submitted
3 Sep 2009
Last updated
8 Apr 2014
Data monitoring committee
Yes

Publications

  • Yoshino T, Hasegawa Y, Takahashi S, Monden N, Homma A, Okami K, Onozawa Y, Fujii M, Taguchi T, de Blas B, Beier F, Tahara M. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10.

    PubMed 23479384

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab, Cisplatin/Carboplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 10 sites in Japan.

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 14 inclusion and 17 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 10 Aug 2012). 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?

Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria (time frame: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011). 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 NCT00971932, 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 8 Apr 2014.

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