Head and Neck CancerPhase 2NCT00216138
Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head & Neck
A Phase 2 study testing Docetaxel, Capecitabine and Premedication in people with Head and Neck Cancer, run by Hoosier Cancer Research Network at 18 sites in United States.
Trial summary
Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. 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?
- Docetaxel, Capecitabine and Premedication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 2004to Sep 2007
- 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
- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck.
- Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.
- Unidimensional measurable disease according to the RECIST
- In-field recurrence, within a prior radiation field only, distant metastatic disease
- Both in-field and metastatic sites of disease will require evaluation by a Radiation Oncologist to consider local radiation therapy first and will be eligible for possible enrollment one month after completion of the radiation therapy.
- Negative pregnancy test
- Patients may have received prior chemotherapy as part of chemoradiation or induction chemotherapy for initial treatment of disease confined to the head and neck region - Patients must have fully recovered from any prior radiation therapy
Who cannot join
- Patients who have relapsed < 6 months after completing a combined modality curative treatment that included a fluoropyrimidine or taxanes
- No brain metastases
- No major neurological disease, including stroke
- No prior chemotherapy regimen for recurrent/metastatic disease
- No prior history of capecitabine usage
- No prior history of docetaxel usage except in the induction setting for head and neck cancer which has been completed for greater than 6 months prior to beginning protocol therapy
Show all 20Show fewer
- No past hypersensitivity to taxanes or 5 FU
- No hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
- No current use of warfarin
- Patients must not be receiving ketoconazole, midazolam, erythromycin, orphenadrine, troleandomycin, cyclosporine or antiepileptics
- Patients must not be treated with any of the following on protocol therapy or within 28 days prior to beginning protocol therapy: sorivudine, brivudine, cimetidine, allopurinol
- Patients must have fully recovered from any prior surgery
- No known HIV seropositivity.
- No serious uncontrolled medical condition, uncontrolled peptic ulcer disease or malabsorption syndrome
- No peripheral neuropathy > grade 1
- Patients with a percutaneous gastrostomy (PEG) must be able take medications by tube.
- No daily consumption of alcohol
- No active infection
- No prior history of malignancy in the last 5 years, excluding in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin or Gleason Grade < VII organ confined prostate cancer.
- No current breastfeeding
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Elkhart Clinic
Elkhart, Indiana, 46515
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, 47714
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Center for Hematology-Oncology of S Michigan
Jackson, Michigan, 49201
Arnett Cancer Care
Lafayette, Indiana, 47904
Medical Consultants, P.C.
Muncie, Indiana, 47303
Center for Cancer Care, Inc., P.C.
New Albany, Indiana, 47150
Helen F. Graham Cancer Center
Newark, Delaware, 19713
Methodist Cancer Center
Omaha, Nebraska, 68114
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Siteman Cancer Center
St Louis, Missouri, 63110
Providence Medical Group
Terre Haute, Indiana, 47802
AP&S Clinic
Terre Haute, Indiana, 47804
About this study
Official title: A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40
Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone.
This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.
Read the detailed description
OUTLINE: This is a multi-center study.
- Dexamethasone and antiemetic premedication1.
- Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle
- Capecitabine: 825 mg/m2 po BID Days 1-14
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy
Performance status: ECOG performance status 0 or 1
Life expectancy: At least 3 months
Hematopoietic:
- ANC of > 1,500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 8 gm/dl
Hepatic:
- Total Bilirubin £ ULN
- Albumin > 3
- Maximum Alk Phos > 2.5 x < 5 x ULN
Renal:
- Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)
Cardiovascular:
- No decompensated congestive heart failure or active angina.
- Clinically significant cardiac disease not well controlled with medication (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction in the past 12 months is not allowed.
Pulmonary:
- Not specified
- Conditions
- Head and Neck Cancer
- Being tested
- Docetaxel, Capecitabine, Premedication
- 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.
DocetaxelDrug
Docetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle
CapecitabineDrug
Capecitabine 825 mg/m2 po bid, days 1-14
PremedicationDrug
Dexamethasone and antiemetic premedication
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Docetaxel + Capecitabine Receives: Drug: Docetaxel; Drug: Capecitabine; Drug: Premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine
Measured: 24 months
Secondary outcomes (5)
To assess toxicity of the combination
Measured: 24 months
To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment
Measured: 24 months
Efficacy and safety analyses on special sub-cohorts
Measured: 24 months
To determine the progression free survival and overall survival
Measured: 24 months
To assess change in analgesic usage with this protocol therapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: Interim analysis results did not meet criteria for second stage of trial
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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche, Walther Cancer Institute
- Investigators
- David Potter, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216138
- Sponsor's protocol ID
- HOG HN02-40
- Status last verified
- Apr 2011
- First submitted
- 12 Sep 2005
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN): Hoosier Oncology Group HN02-40
- ClinicalTrials.gov ID
- NCT00216138
- Acronym / sponsor ID
- HOG HN02-40
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis results did not meet criteria for second stage of trial
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Sanofi, Hoffmann-La Roche, Walther Cancer Institute
- Study start
- Mar 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 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.
Recent progress in treatment of recurrent/metastatic SCCHN has been made with the introduction of the taxanes. Docetaxel as a single agent has a response rate of 22-42% and 17% in patients with recurrent disease. Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU. Previous studies have shown that the capecitabine/docetaxel combination has a synergistic inhibition of tumor growth, resulting in significantly superior efficacy in time to disease progression (TTP), overall survival, median survival and objective tumor response rate compared to docetaxel alone.
This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrent/metastatic SCCHN.
Detailed description
OUTLINE: This is a multi-center study.
- Dexamethasone and antiemetic premedication1.
- Docetaxel: 60 mg/m2 for a 60 minute infusion day 1 of each cycle
- Capecitabine: 825 mg/m2 po BID Days 1-14
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy
Performance status: ECOG performance status 0 or 1
Life expectancy: At least 3 months
Hematopoietic:
- ANC of > 1,500/mm3
- Platelets > 100,000/mm3
- Hemoglobin > 8 gm/dl
Hepatic:
- Total Bilirubin £ ULN
- Albumin > 3
- Maximum Alk Phos > 2.5 x < 5 x ULN
Renal:
- Creatinine clearance of > 50 ml/ min (by Cockcroft-Gault)
Cardiovascular:
- No decompensated congestive heart failure or active angina.
- Clinically significant cardiac disease not well controlled with medication (eg. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction in the past 12 months is not allowed.
Pulmonary:
- Not specified
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Docetaxel, Drug: Capecitabine, Drug: PremedicationDocetaxel + Capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck.
- Recurrent/metastatic disease not amenable to surgery or salvage chemoradiation.
- Unidimensional measurable disease according to the RECIST
- In-field recurrence, within a prior radiation field only, distant metastatic disease
- Both in-field and metastatic sites of disease will require evaluation by a Radiation Oncologist to consider local radiation therapy first and will be eligible for possible enrollment one month after completion of the radiation therapy.
Key exclusion criteria (20 listed)
- Patients who have relapsed < 6 months after completing a combined modality curative treatment that included a fluoropyrimidine or taxanes
- No brain metastases
- No major neurological disease, including stroke
- No prior chemotherapy regimen for recurrent/metastatic disease
- No prior history of capecitabine usage
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 |
|---|---|---|
| DocetaxelDocetaxel 60 mg/m2 for 60 minutes, day 1 of each cycle | Drug | 1 |
| CapecitabineCapecitabine 825 mg/m2 po bid, days 1-14 | Drug | 1 |
| PremedicationDexamethasone and antiemetic premedication | Drug | 1 |
Primary outcome
- To assess response rate in a group of patients receiving combination therapy with docetaxel and capecitabine
Time frame: 24 months
5 secondary outcomes
To assess toxicity of the combination
Time frame: 24 months
To determine whether the status of calpain, calpain activation,(EGFR) expression, Cox-2 expression, TS, TP, DPD, and/or CYP3A4/CYP3A5 will predict treatment
Time frame: 24 months
Efficacy and safety analyses on special sub-cohorts
Time frame: 24 months
To determine the progression free survival and overall survival
Time frame: 24 months
To assess change in analgesic usage with this protocol therapy
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Interim analysis results did not meet criteria for second stage of trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Hoosier Oncology Group Home PageLink 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.
David Potter, M.D. study chair
Hoosier Oncology Group, LLC
18 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 Docetaxel, Capecitabine and Premedication in people with Head and Neck Cancer, run by Hoosier Cancer Research Network at 18 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?
The sponsor lists 7 inclusion and 20 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 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
The study was stopped early (reason given: Interim analysis results did not meet criteria for second stage of trial). Results are not available in the source record.
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 response rate in a group of patients receiving combination therapy with docetaxel and capecitabine (time frame: 24 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 2 May 2011.