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Squamous Cell Carcinoma of the Head and NeckPhase 1NCT01737008

Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck

A Phase 1 study testing dacomitinib, Radiotherapy and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by University Health Network, Toronto at 1 site in Canada.

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

This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN). Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a receptor called the epidermal growth factor receptor… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dacomitinib, Radiotherapy and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
Jan 2013to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Signed voluntary informed consent provided.
  • Patient willing and able to comply with visits, treatment plan, pharmacokinetics, laboratory tests, other study procedures.
  • Escalation: Arm A: patients with local/locally advanced confirmed SCCHN; candidates for radical radiotherapy. Arm B: previously untreated patients, with locally advanced, confirmed SCCHN; candidates for radical concurrent cisplatin-based chemoradiation.
  • Expansion: previously untreated patients, with locally advanced, confirmed SCCHN; HPV-negative candidates for radical concurrent cisplatin-based chemoradiation.Note: Those with primary tumors of head and neck in nasopharynx, skin, or unknown are excluded.
  • Prior treatment of current neoplasm not allowed; must not have received any anti-neoplastic treatment within 2 years.
  • Treatment-related toxicity must have recovered to CTCAE Grade 1 (v.4.0) or baseline, except toxicities not considered a risk. Chronic dysphagia, xerostomia or other effect resulting from prior surgery will not be considered exclusion criterion.
  • ECOG performance status 0-1.
  • Patient must have adequate organ function determined by: Creatinine clearance of ≥ 50 mL/min using formula: Creatinine clearance=[(140-age) x wt (kg) x Constant]/creatinine (µmol/L) [Constant = 1.23 for men; 1.04 for women]. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Leukocytes > 3.0 x 109/L; Hemoglobin > 80 g/L (or > 8 g/dL); Platelets ≥ 100 x 109/L. Total bilirubin ≤ ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN. 12-Lead electrocardiogram (ECG) with normal tracing, or clinically non-significant changes. QTc interval < 480 msec, without history of Torsades de Pointes or other QTc abnormality.

Who cannot join

  • Enrollment in another clinical trial.
  • Prior trial drug use within 30 days or 5 half-lives preceding first dose of study medication.
  • Prior treatment with agents targeted to epidermal growth factor receptor
  • Requirement for drugs highly dependent on CYP2D6 for metabolism - dacomitinib is a potent CYP2D6 inhibitor [See Appendix B and C].
  • Patients taking drugs causing risk for Torsades de Pointes
  • Any acute/chronic medical, psychiatric, laboratory abnormality that investigator finds could increase risks of participation, trial drug administration or could interfere with trial results. Including: History of interstitial lung disease; uncontrolled hypertension, unstable angina, myocardial infarction, symptomatic congestive heart failure within a year, cardiac arrhythmia, diagnosed/suspected congenital long QT syndrome; cardiovascular or vascular disease with anti arrhythmic therapy and/or major changes to medical care within 6 months; active bacterial, fungal or viral infection including hepatitis B or C, and human immunodeficiency virus. Testing not required for patients with no symptoms of infection. History of bleeding disorder, or concurrent medications the investigator finds to potentially lead to unacceptable coagulation function, including: congenital bleeding disorders; acquired bleeding disorder within one year; Other serious uncontrolled medical disorder or active infection that investigator determines may impair ability to receive study treatment. Dementia or altered mental status that limits ability to obtain informed consent and compliance with requirements of protocol.
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  • Breastfeeding/pregnancy. Females with reproductive potential [any female who had menarche and who has not had successful surgical sterilization/is not postmenopausal (defined as amenorrhea >12 consecutive months/women on hormone replacement therapy with serum follicle stimulating hormone level >35 mL.U/mL)] require negative pregnancy test within 72 hours of treatment.
  • Patients of reproductive potential/partners must agree to effective contraception while receiving trial treatment and for 3 months after. Effective contraception will be judgment of principal investigator or designate.
  • Inability or lack of willingness to comply

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Phase I Trial of Dacomitinib Concomitant With Radiotherapy With and Without Cisplatin in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).

Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a receptor called the epidermal growth factor receptor (EGFR). By blocking signals for cancer cells to grow, it is believed to stop or slow the growth of tumor cells.

The dose escalation phase will find the best dose as well as determine the safety of dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion phase will further test the best dose determined in the dose escalation phase for response rate.

Read the detailed description

This is a phase 1 study of the investigational drug, dacomitinib, with radiotherapy and with or without chemotherapy in patients with advanced squamous cell carcinoma of the head and neck (SCCHN).

There are proteins found on the surface of cells called receptors that receive signals and send signals to the cell to grow or to die. Dacomitinib is an oral drug that blocks a receptor called the epidermal growth factor receptor (EGFR) which is found to be too active in SCCHN patients. By blocking the signals for the cancer cells to grow, it is believed to stop or slow the growth of tumor cells. The treatment of SCCHN usually includes chemotherapy and radiation.

The primary objectives of this study will have two phases: a dose escalation phase and a dose expansion phase. The dose escalation phase will find the best dose as well as determine the safety of dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion phase will further test the best dose determined in the dose escalation phase for safety and response rate.

The secondary objectives are to evaluate the pharmacokinetic properties of the combination therapies, and to provide preliminary survival data.

Being tested
dacomitinib, Radiotherapy, Cisplatin
Keywords
Head and neck, Squamous cell carcinoma, Phase 1, Dacomitinib, Radiation, Radiotherapy, Chemotherapy, Chemoradiation, Chemoradiotherapy, Cisplatin, Pharmacokinetics, Maximum tolerated dose, Safety, Human epidermal growth factor receptor, Previously Untreated, Local or Locally Advanced
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell

What participants receive

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

  • dacomitinibDrug

    Also called PF-00299804

    Tablets are administered orally or through a G-Tube, and can be taken with or without food.

  • RadiotherapyRadiation

    Intensity modulated radiation therapy (IMRT) delivered using 4 or 6 MV photons. Patients will receive either the standard dose fractionation radiotherapy or accelerated fractionation radiotherapy.

  • CisplatinDrug

    Also called cisplatinum

    If selected for this arm, cisplatin will be administered intravenously every three weeks after receiving premedications.

Study groups in NCT01737008
Study groupRoleWhat they receive
Dacomitinib with RadiotherapyExperimentalDacomitinib, 15mg to 45mg orally, once daily. Radiotherapy, once daily (Monday to Friday) over six weeks.One day on weeks 2 to 6 the participants will receive treatment twice daily (bid).
Receives: Drug: dacomitinib; Radiation: Radiotherapy
Dacomitinib and ChemoradiotherapyExperimentalDacomitinib: 15mg to 45mg orally, once daily. Radiotherapy: Once daily (Monday to Friday) over seven weeks. Twice daily (bid) treatments may be introduced to compensate for treatment days missed due to statutory holidays, or machine maintenance. Cisplatin: 100mg/m2 intravenously; weeks 1, 4, and 7.
Receives: Drug: dacomitinib; Radiation: Radiotherapy; Drug: Cisplatin

What is being measured

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

  1. Maximum Tolerated Dose (in mg) of Dacomitinib

    Measured: 1 year

  2. To preliminarily evaluate the response rate of the combination of Dacomitinib, Cisplatin and Radiation

    Measured: 1 year

Secondary outcomes (2)

  1. Levels of Dacomitinib in the Blood (Pharmacokinetics) in Combination with Cisplatin and Radiation

    Measured: Days 8, 22 and 43 (+2 day window) after initial dose

  2. Disease free survival, overall survival and locoregional and distant metastasis free survival

    Measured: 6 and 12 months

Timeline

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

  1. First posted29 Nov 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionFeb 2015
  4. Study completionMay 2015

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737008
Sponsor's protocol ID
XDC-001
Status last verified
Jun 2016
First submitted
26 Nov 2012
Last updated
13 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Chiu JW, Chan K, Chen EX, Siu LL, Abdul Razak AR. Pharmacokinetic assessment of dacomitinib (pan-HER tyrosine kinase inhibitor) in patients with locally advanced head and neck squamous cell carcinoma (LA SCCHN) following administration through a gastrostomy feeding tube (GT). Invest New Drugs. 2015 Aug;33(4):895-900. doi: 10.1007/s10637-015-0245-3. Epub 2015 May 5.

    PubMed 25937431

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dacomitinib, Radiotherapy and Cisplatin in people with Squamous Cell Carcinoma of the Head and Neck, run by University Health Network, Toronto at 1 site in Canada.

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 8 inclusion and 9 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 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose (in mg) of Dacomitinib (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01737008, 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 13 Jun 2016.

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