Head and Neck CancerPhase 2NCT00833261
Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase 2 study testing cetuximab, cisplatin and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 4 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cetuximab, cisplatin and intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2008to May 2016
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
- Recurrent disease or second primary SCC
- Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
- Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
- More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy
- Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)
- No signs of carotid exposure
- No primary nasopharyngeal or salivary gland tumor
- Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan
- No distant metastasis
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- ANC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
- Bilirubin < 1.5 mg/dL
- AST or ALT < 2 times upper limit of normal
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded
- No active cardiac disease, including any of the following:
- Unstable angina
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
- Uncontrolled arrhythmia
- Congestive heart failure
- At least 3 heart-related hospitalizations within the past year
- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
- No concurrent medical illness that would impair patient tolerance to therapy or limit survival
- No other invasive malignancy within the past 2 years
- No pre-existing peripheral sensory neuropathy ≥ grade 2
- No prior severe infusion reaction to a monoclonal antibody
- No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery
- Prior cisplatin and cetuximab allowed
- At least 6 months since prior radiotherapy or chemotherapy
- No prior radiotherapy > 75 Gy
- No prior chemotherapy for recurrent head and neck cancer
- Prior chemotherapy as a component of the primary treatment allowed
- No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer
- Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Baylor Research Institute
Dallas, Texas, 75204
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To determine the progression-free survival and local-regional progression in these patients.
- To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
- To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
- Conditions
- Head and Neck Cancer
- Being tested
- cetuximab, cisplatin, intensity-modulated radiation therapy, Nab-Paclitaxel
- Keywords
- recurrent hypopharynx Cancer, recurrent larynx Cancer, recurrent verrucous carcinoma, squamous cell carcinoma, recurrent oral cavity cancer, recurrent metastatic occult primary cancer, recurrent oropharynx cacner, recurrent paranasal sinus and nasal cavity cancer, tongue cancer
- Medical subject headings
- Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma, Verrucous, Carcinoma, Squamous Cell, Mouth Neoplasms, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Also called chemo
cetuximab
cisplatinDrug
Also called chemo
cisplatin
intensity-modulated radiation therapyRadiation
Also called IMRT
IMRT
Nab-PaclitaxelDrug
Also called chemo
Nab-Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Chemotherapy with Concurrent Radiation therapy | Experimental | Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy Receives: Drug: cetuximab; Drug: cisplatin; Radiation: intensity-modulated radiation therapy; Drug: Nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
Measured: 2 year from the date of enrollment
Secondary outcomes (1)
Number of Participants With Acute and Late Toxicities
Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.
Measured: 6 months within the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionSep 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833261
- Sponsor's protocol ID
- CDR0000632295
- Other IDs
- SCCC-04308, CA 225314, 112008-004
- Status last verified
- Nov 2018
- First submitted
- 30 Jan 2009
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Awan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.
PubMed 29346519
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
- ClinicalTrials.gov ID
- NCT00833261
- Acronym / sponsor ID
- CDR0000632295
- Conditions
- Head and Neck Cancer
- Keywords
- recurrent hypopharynx Cancer, recurrent larynx Cancer, recurrent verrucous carcinoma, squamous cell carcinoma, recurrent oral cavity cancer, recurrent metastatic occult primary cancer, recurrent oropharynx cacner, recurrent paranasal sinus and nasal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.
Secondary
- To determine the progression-free survival and local-regional progression in these patients.
- To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
- To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Chemotherapy with Concurrent Radiation therapy | Experimental | Drug: cetuximab, Drug: cisplatin, Radiation: intensity-modulated radiation therapy, Drug: Nab-PaclitaxelNab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy intensity-modulated radiation therapy |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cetuximabAlso: chemocetuximab | Drug | Single Arm: Chemotherapy with Concurrent Radiation therapy |
| cisplatinAlso: chemocisplatin | Drug | Single Arm: Chemotherapy with Concurrent Radiation therapy |
| intensity-modulated radiation therapyAlso: IMRTIMRT | Radiation | Single Arm: Chemotherapy with Concurrent Radiation therapy |
| Nab-PaclitaxelAlso: chemoNab-Paclitaxel | Drug | Single Arm: Chemotherapy with Concurrent Radiation therapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: 2 year from the date of enrollment
The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.
1 secondary outcome
Number of Participants With Acute and Late Toxicities
Time frame: 6 months within the end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29346519Awan MJ, Nedzi L, Wang D, Tumati V, Sumer B, Xie XJ, Smith I, Truelson J, Hughes R, Myers LL, Lavertu P, Wong S, Yao M. Final results of a multi-institutional phase II trial of reirradiation with concurrent weekly cisplatin and cetuximab for recurrent or second primary squamous cell carcinoma of the head and neck. Ann Oncol. 2018 Apr 1;29(4):998-1003. doi: 10.1093/annonc/mdy018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab, cisplatin and intensity-modulated radiation therapy in people with Head and Neck Cancer, run by University of Texas Southwestern Medical Center at 4 sites 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?
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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). 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?
Progression Free Survival (PFS) (time frame: 2 year from the date of enrollment). 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 NCT00833261, 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 21 Aug 2020.