Head and Neck CancerPhase 1NCT00405405
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
A Phase 1 study testing Cisplatin, Docetaxel and Bevacizumab in people with Head and Neck Cancer and Parotid Gland Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer
- What is being tested?
- Cisplatin, Docetaxel and Bevacizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2010
- 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
- Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
- Stage IV disease (T4Nany or TanyN2-3).
- "Oligometastatic" disease is allowable if it is asymptomatic.
- Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is <40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
- Performance status 0-1.
- Creatinine < or = 1.5 mg/dl.
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- ANC > or = 1,800 cells/mm3.
- Platelets > or = 150,000 cells/mm3.
- Hemoglobin > or = 10 g/dl (transfusion is acceptable if needed).
- SGOT and/or SGPT < or = 2.5 times the upper institutional limit of normal.
- INR < or = 2.0.
- Age > or = 18 (informed consent).
Who cannot join
- Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
- Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
- Unstable angina.
- NY Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or stroke within 6 months.
- Clinically significant peripheral vascular disease.
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- Evidence of bleeding diathesis or coagulopathy.
- Presence of brain or spinal cord metastases.
- Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.
- Urine protein: Creatinine ratio > or = 1.0 at screening.*
- Carotid artery exposure or other signs of impending carotid artery hemorrhage.
- History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
- Serious, non-healing wound, ulcer, or bone fracture.
- Prior irradiation that would result in radiotherapy field "overlap."
- Requirement for high dose oral anticoagulation (i.e., goal INR > 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.
- No known allergies to any of the drug therapies being used in this protocol.
- No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Read the detailed description
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
- Conditions
- Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer, Melanoma, Stage IV Head and Neck Cancer
- Being tested
- Cisplatin, Docetaxel, Bevacizumab, Erlotinib, Radiotherapy
- Keywords
- Head and neck cancer, Parotid gland cancer, thyroid gland cancer, melanoma, Chemoradiotherapy, bevacizumab, erlotinib
- Medical subject headings
- Head and Neck Neoplasms, Parotid Neoplasms, Thyroid Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol
- Two cycles during neoadjuvant therapy
- Response assessment at approximately day 36
- Concurrent biochemoradiotherapy
DocetaxelDrug
Also called Taxotere
- Two cycles during neoadjuvant therapy
- Response assessment at approximately day 36
- Concurrent biochemoradiotherapy
BevacizumabDrug
Also called Avastin
- Two cycles during neoadjuvant therapy
- Response assessment at approximately day 36
- Concurrent biochemoradiotherapy
ErlotinibDrug
Also called Erlotinib hydrochloride, Tarceva
- Two cycles during neoadjuvant therapy (dose escalation)
- Response assessment at approximately day 36
- Concurrent biochemoradiotherapy
RadiotherapyRadiation
Also called Radiation therapy, Radiation oncology, XRT
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Bevacizumab; Drug: Erlotinib; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
Measured: Day 36
Secondary outcomes (2)
Determination of Dose Limiting Toxicity (DTL)
To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
Measured: 30 days
Complete Remission Rate
To obtain preliminary data on the complete remission rate for this treatment combination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Pramila Rani Anne, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405405
- Sponsor's protocol ID
- 06C.46
- Other IDs
- 2005-58, 06C.46
- Status last verified
- May 2025
- First submitted
- 29 Nov 2006
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00405405
- Acronym / sponsor ID
- 06C.46
- Conditions
- Head and Neck Cancer, Parotid Gland Cancer, Thyroid Gland Cancer, Melanoma, Stage IV Head and Neck Cancer
- Keywords
- Head and neck cancer, Parotid gland cancer, thyroid gland cancer, melanoma, Chemoradiotherapy, bevacizumab, erlotinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Detailed description
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Cisplatin, Drug: Docetaxel, Drug: Bevacizumab, Drug: Erlotinib, Radiation: RadiotherapyA combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
- Stage IV disease (T4Nany or TanyN2-3).
- "Oligometastatic" disease is allowable if it is asymptomatic.
- Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is <40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
- Performance status 0-1.
Key exclusion criteria (17 listed)
- Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
- Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
- Unstable angina.
- NY Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or stroke within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy | Drug | Treatment |
| DocetaxelAlso: Taxotere* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy | Drug | Treatment |
| BevacizumabAlso: Avastin* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy | Drug | Treatment |
| ErlotinibAlso: Erlotinib hydrochloride, Tarceva* Two cycles during neoadjuvant therapy (dose escalation) * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy | Drug | Treatment |
| RadiotherapyAlso: Radiation therapy, Radiation oncology, XRTRadiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks | Radiation | Treatment |
Primary outcome
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
Time frame: Day 36
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
2 secondary outcomes
Determination of Dose Limiting Toxicity (DTL)
Time frame: 30 days
Complete Remission Rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pramila Rani Anne, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin, Docetaxel and Bevacizumab in people with Head and Neck Cancer and Parotid Gland Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
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 12 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 6 May 2025. 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 United States. 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?
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer (time frame: Day 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.