Head and Neck CancerPhase 2NCT00352118
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
A Phase 2 study testing filgrastim, pegfilgrastim and cisplatin in people with Head and Neck Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. 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?
- filgrastim, pegfilgrastim and cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage IVA or IVB disease
- Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
- Measurable or evaluable disease
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
Show all 13Show fewer
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
- Bilirubin normal
- Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Who cannot join
- Salivary gland, sinus, or nasopharyngeal primary disease
- Evidence of distant metastatic disease
- Pregnant or nursing
- Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
- Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
- Peripheral neuropathy ≥ grade 2
Show all 16Show fewer
- Hearing loss ≥ grade 2
- Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
- Poor nutritional status, in the opinion of the investigator
- Active infection
- Active ischemic heart disease
- Myocardial infarction within the past 6 months
- Prior radiotherapy above the clavicles
- Prior chemotherapy
- Prior surgery to the primary tumor except biopsy
- Concurrent amifostine or other investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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 combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
Read the detailed description
OBJECTIVES:
Primary
- Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
- Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
- Determine the pattern of failure in patients treated with this regimen.
- Evaluate the quality of life of patients treated with this regimen.
- Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.
Tertiary
- Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Evaluate the quality of saliva by examining total protein concentrations.
- Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
- Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
OUTLINE: This is a pilot study.
- Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
- Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.
Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.
Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer
- Being tested
- filgrastim, pegfilgrastim, cisplatin, docetaxel, fluorouracil
- Keywords
- oral complications of radiation therapy, oral complications of chemotherapy, mucositis, xerostomia, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx
- Medical subject headings
- Head and Neck Neoplasms, Mucositis, Xerostomia, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
Also called G-CSF, Neupogen
subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.
pegfilgrastimBiological
Also called Neulasta, G-CSF
If applicable on day 5, repeating every 3 weeks for 2 courses.
cisplatinDrug
Also called CDDP, cisplatinum, cis-diamminedichloridoplatinum, Platinol AQ
Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.
docetaxelDrug
Also called Taxotere(R)
Intravenous over 1 hour on day 1.
fluorouracilDrug
Also called 5-FU, 5-fluorouracil, Adrucil
Intravenous continuously on days 1-4.
conventional surgeryProcedure or surgery
Also called surgery
As appropriate, neck dissection.
radiation therapyRadiation
Also called radiation
60 Gy 5 days/week x 6 weeks with cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Low Dose Radiation | Experimental | Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol. Receives: Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Procedure: conventional surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Feeding Tube Dependency
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Measured: at 12 months
Secondary outcomes (6)
Number of Days With Progression-free Survival
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Measured: Between date of registration to date of first treatment failure or death.
Number of Days - Overall Survival
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing RECIST criteria.
Measured: Between date of registration to date of death.
Number of Days With Disease Free Survival
All patients were non-evaluable and study was terminated early. There is no measure of outcome. RECIST criteria measurement.
Measured: From Date of Registration to Date of First Treatment Failure or Death
Time to Treatment Failure
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Measure using RECIST criteria.
Measured: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
Swallowing Ability - Quality of Life Scores
All patients were non-evaluable and study was terminated early. There is no measure of outcome. Utilizing Swallowing Portion of ASHA Functional Communication Measure for Swallowing (FCM) and Dysphagia Outcome and Severity Scale (DOSS).
Measured: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
Measured: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startMar 2006
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Low dose radiation treatment was not appropriate for these patients.
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.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frank G. Ondrey, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352118
- Sponsor's protocol ID
- 2005LS012
- Other IDs
- UMN-0502M67486
- Status last verified
- Dec 2017
- First submitted
- 13 Jul 2006
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00352118
- Acronym / sponsor ID
- 2005LS012
- Conditions
- Head and Neck Cancer
- Keywords
- oral complications of radiation therapy, oral complications of chemotherapy, mucositis, xerostomia, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low dose radiation treatment was not appropriate for these patients.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Jul 2006 (estimated)
- Results
- Posted 21 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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 combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
Detailed description
OBJECTIVES:
Primary
- Determine feeding tube dependency at 12 months in patients with locally advanced head and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by cisplatin and reduced-dose radiotherapy.
Secondary
- Determine the progression-free, disease-free, and overall survival of patients treated with this regimen.
- Determine the pattern of failure in patients treated with this regimen.
- Evaluate the quality of life of patients treated with this regimen.
- Assess pre- and post-treatment swallowing ability of patients and the impact on their quality of life.
Tertiary
- Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Evaluate the quality of saliva by examining total protein concentrations.
- Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular endothelial growth factor) in the saliva of these patients.
- Determine the degree of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
- Compare salivary flow rates with the grade of mucositis and xerostomia of patients receiving chemotherapy with radiotherapy for head and neck malignancy.
OUTLINE: This is a pilot study.
- Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day 5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial or clinical complete response proceed to chemoradiotherapy 3 weeks later.
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5 days a week for 6 weeks.
- Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with residual neck disease or disease initially staged at N2 or greater undergo neck dissection.
Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and examine the grade of mucositis and xerostomia.
Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Low Dose Radiation | Experimental | Biological: filgrastim, Biological: pegfilgrastim, Drug: cisplatin, Drug: docetaxel, Drug: fluorouracil, Procedure: conventional surgery, Radiation: radiation therapyPatients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed squamous cell carcinoma of the head and neck
- Measurable or evaluable disease
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Key exclusion criteria (16 listed)
- Salivary gland, sinus, or nasopharyngeal primary disease
- Evidence of distant metastatic disease
- Pregnant or nursing
- Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
- Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
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 |
|---|---|---|
| filgrastimAlso: G-CSF, Neupogensubcutaneously on Days 5-14, repeating every 3 weeks for 2 courses. | Biological | Chemotherapy + Low Dose Radiation |
| pegfilgrastimAlso: Neulasta, G-CSFIf applicable on day 5, repeating every 3 weeks for 2 courses. | Biological | Chemotherapy + Low Dose Radiation |
| cisplatinAlso: CDDP, cisplatinum, cis-diamminedichloridoplatinum, Platinol AQIntravenous over 1 hour on day 1, every 3 weeks for 3 courses. | Drug | Chemotherapy + Low Dose Radiation |
| docetaxelAlso: Taxotere(R)Intravenous over 1 hour on day 1. | Drug | Chemotherapy + Low Dose Radiation |
| fluorouracilAlso: 5-FU, 5-fluorouracil, AdrucilIntravenous continuously on days 1-4. | Drug | Chemotherapy + Low Dose Radiation |
| conventional surgeryAlso: surgeryAs appropriate, neck dissection. | Procedure or surgery | Chemotherapy + Low Dose Radiation |
| radiation therapyAlso: radiation60 Gy 5 days/week x 6 weeks with cisplatin | Radiation | Chemotherapy + Low Dose Radiation |
Primary outcome
Number of Patients With Feeding Tube Dependency
Time frame: at 12 months
All patients were non-evaluable and study was terminated early. There is no measure of outcome.
6 secondary outcomes
Number of Days With Progression-free Survival
Time frame: Between date of registration to date of first treatment failure or death.
Number of Days - Overall Survival
Time frame: Between date of registration to date of death.
Number of Days With Disease Free Survival
Time frame: From Date of Registration to Date of First Treatment Failure or Death
Time to Treatment Failure
Time frame: Number of Days from Complete or Partial Response to First Date of Recurrence or Progression
Swallowing Ability - Quality of Life Scores
Time frame: Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.
Quality of Life (QOL) by Functional Assessment of Cancer Therapy-H&N QOL Questionnaire
Time frame: baseline, before chemoradiotherapy, 1 month after the last radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Frank G. Ondrey, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
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 filgrastim, pegfilgrastim and cisplatin in people with Head and Neck Cancer, run by Masonic Cancer Center, University of Minnesota 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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 28 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2009). 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?
Number of Patients With Feeding Tube Dependency (time frame: at 12 months). 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 28 Dec 2017.