Head and Neck CancerPhase 2NCT00203905
A Study of Chemoradiotherapy for Intermediate Stage/Selected Stage IV Cancers of the Head and Neck
A Phase 2 study testing 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab and 5-Fluorouracil, Hydroxyurea-[FHX] in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in… 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?
- 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab and 5-Fluorouracil, Hydroxyurea-[FHX]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Nov 2008
- Phase
- Phase 2
- 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
- Patients must have stage II-III (carcinoma of head and neck, including oral cavity, pharynx, larynx, paranasal sinuses and cervical esophagus). Selected patients with stage disease (T will also be considered for enrolment). Therapy is given with curative intent. Patients with clinical N2 or N3 disease are excluded.
- Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of initial organ preserving surgery will be determined in each patient prior to therapy at the discretion of the treating surgeon. Salvage surgery and neck dissection will be allowed for suspicious or evident residual disease at the completion of the treatment regimen.
- Measurable disease is not required.
- Patients must have a histologically or cytologically confirmed diagnosis of carcinoma of the head and neck.
- No prior exposure to chemotherapy or radiotherapy for a malignancy of the head and neck.
- Patients must have ECOG performance status of 0-2.
- Age 18 years of age and older.
- Patients must have normal organ and bone marrow function.
Who cannot join
- Receiving any other investigational agents
- Recent (within 6 months) myocardial infarction, New York Heart Association (NYHA) - Class H or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to treatment in the study
- Serious, non-healing wound, ulcer, or bone fracture.
- History of recurrent or chronic deep vein thrombosis or pulmonary embolus
- History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic or thrombotic stroke within the last 6 months
- Uncontrolled hypertension
Show all 18Show fewer
- Evidence of bleeding diathesis or coagulopathy
- History of hemoptysis
- Anatomic lesion that increases the risk of serious hemorrhage (e.g. invasion of a major vessel by tumor).
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- Current ongoing treatment with any dose of warfarin or its equivalent.
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 0.
- Fine needle aspirations, indwelling catheter placement, or significant traumatic injury within 7 days prior to Day 0
- Anticipation of need for major surgical procedure during the course of the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to rhuMAb VEUF or other agents used in the study.
- History of a concurrent malignancy or a history of a prior malignancy within the past 3 years.
- Pregnant women
- HIV-positive patients receiving combination anti-retroviral therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Concomitant Chemoradiotherapy With 5-Fluorouracil/Hydroxyurea Compared to FHX Plus Bevacizumab for Intermediate Stage and Selected Stage IV Cancers of the Head and Neck
The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea (FHX) alone.
Read the detailed description
In this study, we intend to explore the feasibility and the effects of adding bevacizumab to Fl-TX in patients with intermediate stage head and neck cancer and selected patients with stage IV disease. As mentioned previously, although single modality therapy (surgery or radiotherapy alone) is often used to treat patients with Stage II head and neck malignancies, with substantial success, still there is a sizeable group of patients (approximately 30% or 40%) who fail these treatments, and represent with locoregional recurrences which are much more difficult to treat. Furthermore, the common use of radical surgery in many instances leads to loss of organ function.
Based on this knowledge, we feel that it is justifiable to include stage II patients (T2NO) in combined chemoradiation studies. Our extensive experience using chemoradiotherapy in patients with regionally advanced non-metastatic Stage 4 cancers of the head and neck area suggests that selected patients with low nodal status (Nondisease) including those with T4 primaries (i.e. T4 NO MO and T4 Nl MO) have a lower risk of distant failure than patients that present with higher nodal status (N2 and N3 disease). Aggressive combined locoregional therapies such as the one that will be administered in the study, are in our opinion appropriate for this group of patients as they address the major concern which is locoregional failure.
The primary goal of the study is exploration of the pharmacodynamic effects of bevacizumab (10 mg/kg) on appropriate markers of angiogenesis in tumor tissue in comparison to a non-bevacizumab containing chemoradiation regimen (FHX alone). These results will be correlated with a number of clinical endpoints including rapidity of clinical response, locoregional control rates, time to progression, need of salvage surgery, overall survival and measures of QOL and organ function. The predictive and prognostic value of specific molecular markers in patients with HNC will also be evaluated. In order to shorten the total duration of treatment without affecting the total administered dose, we have modified our traditional radiation schedule in FHX to include two treatment daily fractions as opposed to one. This modification will allow for the completion of all treatment in 4 to 5 cycles as opposed to the traditional 6 to 7 cycles. Given this modification in the radiation schedule, we considered it prudent to include a control arm (modified FHX) in addition to B-FHX, within a randomized design. The control arm will also help with the interpretation of the results obtained with the measurement of the correlative markers of angiogenesis.
- Conditions
- Head and Neck Cancer
- Being tested
- 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab, 5-Fluorouracil, Hydroxyurea-[FHX]
- Keywords
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Fluorouracil, Hydroxyurea-[FHX], BevacizumabDrug
Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
5-Fluorouracil, Hydroxyurea-[FHX]Drug
Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Hydroxyurea at 500 mg PO q 12 hours x 6 days (11 total doses); Infusion of 5-FU (600 mg/m2/day x 5 days [120 hours] Receives: Drug: 5-Fluorouracil, Hydroxyurea-[FHX] |
| B | Experimental | Bevacizumab: 10 mg/kg will be given as a 90-minute infusion Receives: Drug: 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the time to progression free survival in patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen
Measured: From randomization until disease progression or death from any cause
Secondary outcomes (1)
To explore the pharmacodynamic changes induced on selected markers of angiogenesis by the addition of bevacizumab to FHX and compare them to those induced by FHX alone
Measured: Baseline, week 2, and completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2007
- Study completionNov 2008
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.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203905
- Sponsor's protocol ID
- 12652A
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2005
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Concomitant Chemoradiotherapy With 5-Fluorouracil/Hydroxyurea Compared to FHX Plus Bevacizumab for Intermediate Stage and Selected Stage IV Cancers of the Head and Neck
- ClinicalTrials.gov ID
- NCT00203905
- Acronym / sponsor ID
- 12652A
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Sep 2005 (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.
The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea (FHX) alone.
Detailed description
In this study, we intend to explore the feasibility and the effects of adding bevacizumab to Fl-TX in patients with intermediate stage head and neck cancer and selected patients with stage IV disease. As mentioned previously, although single modality therapy (surgery or radiotherapy alone) is often used to treat patients with Stage II head and neck malignancies, with substantial success, still there is a sizeable group of patients (approximately 30% or 40%) who fail these treatments, and represent with locoregional recurrences which are much more difficult to treat. Furthermore, the common use of radical surgery in many instances leads to loss of organ function.
Based on this knowledge, we feel that it is justifiable to include stage II patients (T2NO) in combined chemoradiation studies. Our extensive experience using chemoradiotherapy in patients with regionally advanced non-metastatic Stage 4 cancers of the head and neck area suggests that selected patients with low nodal status (Nondisease) including those with T4 primaries (i.e. T4 NO MO and T4 Nl MO) have a lower risk of distant failure than patients that present with higher nodal status (N2 and N3 disease). Aggressive combined locoregional therapies such as the one that will be administered in the study, are in our opinion appropriate for this group of patients as they address the major concern which is locoregional failure.
The primary goal of the study is exploration of the pharmacodynamic effects of bevacizumab (10 mg/kg) on appropriate markers of angiogenesis in tumor tissue in comparison to a non-bevacizumab containing chemoradiation regimen (FHX alone). These results will be correlated with a number of clinical endpoints including rapidity of clinical response, locoregional control rates, time to progression, need of salvage surgery, overall survival and measures of QOL and organ function. The predictive and prognostic value of specific molecular markers in patients with HNC will also be evaluated. In order to shorten the total duration of treatment without affecting the total administered dose, we have modified our traditional radiation schedule in FHX to include two treatment daily fractions as opposed to one. This modification will allow for the completion of all treatment in 4 to 5 cycles as opposed to the traditional 6 to 7 cycles. Given this modification in the radiation schedule, we considered it prudent to include a control arm (modified FHX) in addition to B-FHX, within a randomized design. The control arm will also help with the interpretation of the results obtained with the measurement of the correlative markers of angiogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: 5-Fluorouracil, Hydroxyurea-[FHX]Hydroxyurea at 500 mg PO q 12 hours x 6 days (11 total doses); Infusion of 5-FU (600 mg/m2/day x 5 days [120 hours] |
| B | Experimental | Drug: 5-Fluorouracil, Hydroxyurea-[FHX], BevacizumabBevacizumab: 10 mg/kg will be given as a 90-minute infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have stage II-III (carcinoma of head and neck, including oral cavity, pharynx, larynx, paranasal sinuses and cervical esophagus). Selected patients with stage disease (T will also be considered for enrolment). Therapy is given with curative intent. Patients with clinical N2 or N3 disease are excluded.
- Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of initial organ preserving surgery will be determined in each patient prior to therapy at the discretion of the treating surgeon. Salvage surgery and neck dissection will be allowed for suspicious or evident residual disease at the completion of the treatment regimen.
- Measurable disease is not required.
- Patients must have a histologically or cytologically confirmed diagnosis of carcinoma of the head and neck.
- No prior exposure to chemotherapy or radiotherapy for a malignancy of the head and neck.
Key exclusion criteria (18 listed)
- Receiving any other investigational agents
- Recent (within 6 months) myocardial infarction, New York Heart Association (NYHA) - Class H or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to treatment in the study
- Serious, non-healing wound, ulcer, or bone fracture.
- History of recurrent or chronic deep vein thrombosis or pulmonary embolus
- History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic or thrombotic stroke within the last 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 |
|---|---|---|
| 5-Fluorouracil, Hydroxyurea-[FHX], BevacizumabHydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours) | Drug | B |
| 5-Fluorouracil, Hydroxyurea-[FHX]Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours) | Drug | A |
Primary outcome
To evaluate the time to progression free survival in patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen
Time frame: From randomization until disease progression or death from any cause
1 secondary outcome
To explore the pharmacodynamic changes induced on selected markers of angiogenesis by the addition of bevacizumab to FHX and compare them to those induced by FHX alone
Time frame: Baseline, week 2, and completion of therapy
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 17 Jan 2014.
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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.
Everett Vokes, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab and 5-Fluorouracil, Hydroxyurea-[FHX] in people with Head and Neck Cancer, run by University of Chicago 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 8 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 17 Jan 2014. 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 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?
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?
To evaluate the time to progression free survival in patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen (time frame: From randomization until disease progression or death from any cause). 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 17 Jan 2014.