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Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)Phase 1NCT00627835

Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

A Phase 1 study testing sorafenib and sorafenib and cisplatin in people with Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN), run by British Columbia Cancer Agency at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sorafenib and sorafenib and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Start not givento not given
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

  • Inclusion Criteria: Treatment Group 1 (Cohorts 1 \& 2) - Radiation and Sorafenib Only.
  • Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Histological or cytological confirmation is required. The disease must be considered to be potentially curable with radiation only.
  • Stage III or IV disease (UICC/AJCC classification, 6th edition)
  • Age ≥18
  • Patients for whom concurrent cisplatinum is contraindicated due to poor patient tolerance (significant weight loss > 10% of body weight, mild renal dysfunction, ototoxicity, neuropathy, or age >70) yet deemed fit for radical radiation.
  • Signed written consent.
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  • Availability for follow-up after treatment.
  • If the patient is fertile he/she is aware of the risk of becoming pregnant or fathering children and will use adequate contraception (oral contraception, IUD, diaphragm and spermicide or male condom and spermicide) throughout therapy and for at least 2 weeks after therapy.
  • Life expectancy greater than 6 months
  • Inclusion Criteria: Treatment group 2 (Cohorts 3 to 5) - Radiation, Sorafenib and Cisplatin.
  • Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Histological or cytological confirmation is required. The disease must be considered to be potentially curable by combined chemoradiation.
  • Stage III or IV disease (UICC/AJCC classification, 6th edition)
  • Age ≥18.
  • Signed written consent.
  • Availability for follow-up after treatment.
  • If the patient is fertile, he/she is aware of the risk of becoming pregnant or fathering children and will use adequate contraception (oral contraception, IUD, diaphragm and spermicide or male condom and spermicide) throughout therapy and for at least 3 months after therapy.
  • Life expectancy greater than 6 months

Who cannot join

  • Treatment Group 1 (Cohorts 1 \& 2) - Radiation and Sorafenib Only.
  • ECOG performance status 3 or 4
  • Absolute neutrophil count <1.0 X 109/L, platelet count <100 X 109/L or hemoglobin <90 g/L.
  • Serum bilirubin ≥1.5 times ULN or AST/ALT ≥ 2.5 times ULN.
  • Calculated creatinine clearance (Cockcroft-Gault) <40 mL/min. For patients in whom the calculated creatinine clearance is borderline, GFR may be estimated by nuclear renogram with the creatinine clearance ≥ 40 mL/min to be eligible.
  • Uncontrolled hypertension despite adequate anti-hypertensive medications
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  • Bleeding diathesis
  • Significant inter-current illness that will interfere with the radiation therapy during the trial such as HIV infection, pulmonary compromise, active significant alcohol abuse, active infection or febrile illness
  • Any history of myocardial infarction, congestive heart failure (NY Heart Association Class 3 or 4), any history of ventricular arrhythmias, angina or active coronary heart disease within 6 months.
  • Primary cancers of the nasal and paranasal cavities, and of the nasopharynx.
  • Evidence of distant metastases. If based on the best available clinical evidence the investigator wishes to enroll the subject on trial, discussion and documentation with one of the principal investigators is required.
  • Weight loss greater than 25% of usual body weight in the 3 months preceding trial entry.
  • High risk for poor compliance with therapy or follow-up as assessed by investigator.
  • Pregnant or lactating women.
  • Prior radiation therapy to greater than 30% of the bone marrow
  • Prior experimental therapy for cancer within 30 days of entering the trial.
  • Prior radiation for head and neck cancer.
  • Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence and a clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix. However, any patient with previous invasive breast cancer, prostate cancer or melanoma is excluded.
  • Exclusion Criteria: Treatment group 2 (Cohorts 3 to 5) - Radiation, Sorafenib and Cisplatin.
  • ECOG performance status 3 or 4
  • Absolute neutrophil count <1.0 X 109/L, platelet count <100 X 109/L or hemoglobin <90 g/L.
  • Serum bilirubin ≥1.5 times ULN or AST/ALT ≥ 2.5 times ULN.
  • Calculated creatinine clearance (Cockcroft-Gault) <55 mL/min. For patients in whom the calculated creatinine clearance is borderline, GFR may be estimated by nuclear renogram with the creatinine clearance ≥ 55 mL/min to be eligible.
  • Uncontrolled hypertension despite adequate anti-hypertensive medications
  • Bleeding diathesis
  • Significant inter-current illness that will interfere with the chemotherapy or radiation therapy during the trial such as HIV infection, cardiac insufficiency, pulmonary compromise, active significant alcohol abuse, active infection or febrile illness,
  • Any history of myocardial infarction, any history of ventricular arrhythmias, angina or active coronary heart disease within 6 months. Significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatin.
  • Primary cancers of the nasal and paranasal cavities, and of the nasopharynx.
  • Evidence of distant metastases. If based on the best available clinical evidence the investigator wishes to enroll the subject on trial, discussion and documentation with one of the principal investigators is required.
  • Symptomatic peripheral neuropathy ≥ grade 2.
  • Clinically significant sensori-neural hearing impairment which may be exacerbated by cisplatin (audiometric abnormalities without corresponding clinical hearing impairment will not be grounds for exclusion)
  • Weight loss greater than 20% of usual body weight in the 3 months preceding trial entry.
  • High risk for poor compliance with therapy or follow-up as assessed by investigator.
  • Pregnant or lactating women.
  • Prior radiation therapy to greater than 30% of the bone marrow
  • Prior experimental therapy for cancer within 30 days of entering the trial.
  • Prior radiation for head and neck cancer.
  • Patients with prior cancers, except: those diagnosed more than five years ago with no evidence of disease recurrence and a clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix. However, any patient with previous invasive breast cancer, prostate cancer or melanoma is excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase I Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)

The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population.

Read the detailed description

Squamous cell carcinoma of the head and neck is a relatively common malignancy in both Canada and the United States. Despite advancements made with the demonstration of improved outcomes for concurrent platinum based chemotherapy with radical radiation in locally advanced SCCHN, approximately 50% of cases will recur. The current treatment of locoregionally recurrent/metastatic SCCHN is palliative in intent, with a median survival in this population of 6-8 months. Thus improvements to the current backbone treatment of locally advanced SCCHN, that is platinum based chemotherapy with radical radiation, are desperately needed.

This is a non-randomized, open-label, phase I dose escalation trial of neoadjuvant Sorafenib and concurrent Sorafenib, Cisplatin and radiation in locally advanced squamous cell carcinomas of the head and neck (SCCHN).

Being tested
sorafenib, sorafenib and cisplatin
Keywords
squamous cell carcinoma, head and neck, Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

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

  • sorafenibDrug

    Cohort 1 - sorafenib 200 mg PO bid concurrent with radiation

  • sorafenibDrug

    • Cohort 2 - sorafenib 400 mg PO bid concurrent with radiation

  • sorafenib and cisplatinDrug

    Cohort 3 - sorafenib 200 mg PO bid / cisplatin 75 mg/m2 weeks 1, 4 and 7

  • sorafenib and cisplatinDrug

    • Cohort 4 - sorafenib 400 mg PO bid/ cisplatin 75 mg/m2 weeks 1, 4 and 7

  • sorafenib and cisplatinDrug

    Cohort 5 - sorafenib 400 mg PO bid/ cisplatin 100 mg/m2 weeks 1, 4 and 7

Study groups in NCT00627835
Study groupRoleWhat they receive
Treatment Group 1: Cohort 1ExperimentalCohort 1 - sorafenib 200 mg PO bid concurrent with radiation
Receives: Drug: sorafenib
Treatment Group 1: sorafenib and radiation: Cohort 2ExperimentalCohort 2 - sorafenib 400 mg PO bid concurrent with radiation
Receives: Drug: sorafenib
Treatment Group 2: Cohort 3ExperimentalCohort 3 - sorafenib 200 mg PO bid / cisplatin 75 mg/m2 weeks 1, 4 and 7
Receives: Drug: sorafenib and cisplatin
Treatment Group 2: Cohort 4Experimentalo Cohort 4 - sorafenib 400 mg PO bid/ cisplatin 75 mg/m2 weeks 1, 4 and 7
Receives: Drug: sorafenib and cisplatin
Treatment Group 2:Cohort 5ExperimentalCohort 5 - sorafenib 400 mg PO bid/ cisplatin 100 mg/m2 weeks 1, 4 and 7
Receives: Drug: sorafenib and cisplatin

What is being measured

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

  1. To assess the safety of neoadjuvant BAY 43-9006 (sorafenib) and concurrent BAY 43-9006 with radiation in a cohort of SCCHN

    Measured: ongoing

Secondary outcomes (1)

  1. MTD Maximal tolerated dose

    Measured: ongoing

Timeline

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

  1. First posted3 Mar 2008 (estimated)

Why it stopped: Site decided not to open this study

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00627835
Sponsor's protocol ID
OZM-003
Status last verified
Nov 2010
First submitted
14 Feb 2008
Last updated
20 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sorafenib and sorafenib and cisplatin in people with Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN), run by British Columbia Cancer Agency 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 17 inclusion and 38 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: withdrawn, as of the sponsor's last update on 20 Jul 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 was withdrawn before enrolling participants, so there are no results.

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?

To assess the safety of neoadjuvant BAY 43-9006 (sorafenib) and concurrent BAY 43-9006 with radiation in a cohort of SCCHN (time frame: ongoing). 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 NCT00627835.

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 20 Jul 2016.

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