Head and Neck CancerPhase 2NCT00485485
Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer
A Phase 2 study testing Imatinib Mesylate and Docetaxel in people with Head and Neck Cancer and Squamous Cell Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Cancer
- What is being tested?
- Imatinib Mesylate and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2010
- 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
- A written, voluntary informed consent form must be completed prior to beginning any study procedure.
- Patients >/= 18 years of age.
- Histologically documented diagnosis of head and neck squamous cell cancer
- At least one measurable site of disease and can be assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
- Performance status 0-2 (Eastern Cooperative Oncology Group, ECOG)
- Patients must have adequate hepatic, renal, and bone marrow function, defined as the following: (1) total bilirubin < 1.5 * Upper Limits of Normal (ULN); (2) aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) < 2.5 * ULN; (3) creatinine < 1.5 * ULN; (4) ANC > 1.5 * 10^9/L; (5) platelets > 100 * 10^9/L.
- Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control (i.e. condoms, diaphragm) throughout the study and for up to 3 months following discontinuation of study drug.
- Patients who have not been treated for recurrent or metastatic head and neck squamous cell carcinomas (HNSCC) (i.e. Patients who have been treated with chemotherapy for induction/adjuvant or concurrent therapy with radiation in the setting of definitive treatment but have now developed recurrent or metastatic disease are eligible).
Who cannot join
- Prior exposure to docetaxel or imatinib mesylate.
- Patient has received any other investigational agents within 30 days of first day of study drug dosing.
- Patients with myocardial infarction within the past 6 months or New York Heart Association class 3 or 4 congestive heart failure.
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).
- Patient has unstable brain metastasis. Unstable brain metastasis is defined as patients on steroid medication to control symptoms or patient with motor neurologic compromise due to brain metastasis. Patients with treated brain metastasis are eligible if they are > 6 weeks out from therapy and off all steroid medication.
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- Patient has known chronic liver disease (i.e., chronic active hepatitis or cirrhosis).
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV patients are at much greater risk of infection when receiving highly myelosuppressive agents (docetaxel and imatinib) and for safety reasons are not eligible for this trial.
- Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
- Patient previously received radiotherapy to >/= 25 % of the bone marrow
- Patient had a major surgery within 2 weeks prior to study entry.
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Patients must agree not to use herbal remedies or other over-the-counter biologics (i.e. shark cartilage)
- History of hypersensitivity to docetaxel or other taxane therapy.
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
- Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg daily for catheter related anticoagulation are eligible for the study.
- Prior pericardial effusion requiring intervention such as pericardiocentesis or pericardial window within 2 months of study entry.
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
- Patients with a history of Regional Ileitis, Colitis, or Crohn's disease, or any other relevant medical history related to the integrity of the bowel wall as there may be an increased risk of bowel perforation with the combination of Docetaxel and Imatinib.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
Primary Objective:
- To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).
Read more
Secondary Objectives:
- To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
- To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R).
- To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
- To assess the rate of survival.
Read the detailed description
Imatinib mesylate is designed to block certain proteins important in the growth of cancer. Docetaxel is designed to target and destroy cancer cells.
If you are found to be eligible to take part in this study, you will take 4 imatinib mesylate tablets by mouth once a day with a meal and a large glass of water (about 8-10 ounces.) A treatment cycle on this study is 21 days. You should keep normal eating habits, however a low-fat breakfast is recommended (for example, a light continental breakfast of toast and juice). Foods and drinks containing caffeine or grapefruit should be avoided. You should wait at least 1 hour after taking the last tablet before going to bed. If vomiting occurs, do not take any extra study medication.
You will be given a patient diary to record when you take your medication. You should bring the diary to each clinic visit, and the study nurse will review it each time.
Docetaxel will be given through a vein in your arm on the first day of each 21-day treatment cycle for a total of 6 cycles. The infusion will take 1 hour.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and allergic reactions. You will take dexamethasone by mouth twice a day on the day before the docetaxel infusion, the day of the infusion, and the day after infusion. You will receive an extra dose of dexamethasone (either through a needle in a vein or by mouth) on the day of infusion of the chemotherapy either through a needle in a vein or by mouth.
Every 3 weeks while on this study, you will have a physical exam, including measurement of your vital signs and weight, and a performance status evaluation. During the first 4 weeks, blood (about 3 teaspoons each time) will be drawn once a week for routine tests. After that, blood (about 3 teaspoons each time) will be drawn once at Week 5, once at Week 7, and then every 3 weeks after that. In addition, your tumor will be measured by a computed tomography (CT) or magnetic resonance imaging (MRI) scan every 6 weeks (at Weeks 7, 13, and 19).
If you develop any intolerable symptoms or certain changes in your blood tests, your treatment may be delayed and/or the dose may be decreased until the symptoms are gone. It may even be necessary to stop your treatment. You will be informed of any changes in your dosing schedule or in the doses of your medication after your doctor evaluates you in the clinic.
You may receive up to 6 cycles of the study treatment. Your continued participation in this study depends on how the cancer responds to the study drugs. Your doctor may decide to take you off this study if you experience intolerable side effects or the medical condition gets worse.
After you have completed all of your treatment, you will have an end-of-study visit. At this visit you will have a physical exam, including measurement of your vital signs and weight. You will have a performance status evaluation. You will have blood (about 3-4 teaspoons) drawn for routine tests. Your tumor will be measured by a CT or MRI scan.
This is an investigational study. Imatinib mesylate is FDA approved and docetaxel are FDA approved for other types of cancer however their use together in this study is investigational. Dexamethasone is required to be given with docetaxel. All three drugs are commercially available. Up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Being tested
- Imatinib Mesylate, Docetaxel
- Keywords
- Head and Neck Cancer, Squamous Cell Cancer, Imatinib Mesylate, Gleevec, Imatinib, STI571, Docetaxel, Taxotere
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called Gleevec, Imatinib, STI571
400 mg by mouth daily
DocetaxelDrug
Also called Taxotere
60 mg/m^2 by vein (IV) over 1 hour every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate + Docetaxel | Experimental | Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks Receives: Drug: Imatinib Mesylate; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Response Rate
Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
Measured: At 6 weeks reconfirmed 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
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 M.D. Anderson Cancer 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Anne S. Tsao, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485485
- Sponsor's protocol ID
- 2006-0362
- Status last verified
- Aug 2012
- First submitted
- 12 Jun 2007
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT00485485
- Acronym / sponsor ID
- 2006-0362
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Keywords
- Head and Neck Cancer, Squamous Cell Cancer, Imatinib Mesylate, Gleevec, Imatinib, STI571, Docetaxel, Taxotere
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Posted 29 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).
Secondary Objectives:
- To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
- To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of Platelet-derived growth factor receptors (PDGF-R).
- To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
- To assess the rate of survival.
Detailed description
Imatinib mesylate is designed to block certain proteins important in the growth of cancer. Docetaxel is designed to target and destroy cancer cells.
If you are found to be eligible to take part in this study, you will take 4 imatinib mesylate tablets by mouth once a day with a meal and a large glass of water (about 8-10 ounces.) A treatment cycle on this study is 21 days. You should keep normal eating habits, however a low-fat breakfast is recommended (for example, a light continental breakfast of toast and juice). Foods and drinks containing caffeine or grapefruit should be avoided. You should wait at least 1 hour after taking the last tablet before going to bed. If vomiting occurs, do not take any extra study medication.
You will be given a patient diary to record when you take your medication. You should bring the diary to each clinic visit, and the study nurse will review it each time.
Docetaxel will be given through a vein in your arm on the first day of each 21-day treatment cycle for a total of 6 cycles. The infusion will take 1 hour.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and allergic reactions. You will take dexamethasone by mouth twice a day on the day before the docetaxel infusion, the day of the infusion, and the day after infusion. You will receive an extra dose of dexamethasone (either through a needle in a vein or by mouth) on the day of infusion of the chemotherapy either through a needle in a vein or by mouth.
Every 3 weeks while on this study, you will have a physical exam, including measurement of your vital signs and weight, and a performance status evaluation. During the first 4 weeks, blood (about 3 teaspoons each time) will be drawn once a week for routine tests. After that, blood (about 3 teaspoons each time) will be drawn once at Week 5, once at Week 7, and then every 3 weeks after that. In addition, your tumor will be measured by a computed tomography (CT) or magnetic resonance imaging (MRI) scan every 6 weeks (at Weeks 7, 13, and 19).
If you develop any intolerable symptoms or certain changes in your blood tests, your treatment may be delayed and/or the dose may be decreased until the symptoms are gone. It may even be necessary to stop your treatment. You will be informed of any changes in your dosing schedule or in the doses of your medication after your doctor evaluates you in the clinic.
You may receive up to 6 cycles of the study treatment. Your continued participation in this study depends on how the cancer responds to the study drugs. Your doctor may decide to take you off this study if you experience intolerable side effects or the medical condition gets worse.
After you have completed all of your treatment, you will have an end-of-study visit. At this visit you will have a physical exam, including measurement of your vital signs and weight. You will have a performance status evaluation. You will have blood (about 3-4 teaspoons) drawn for routine tests. Your tumor will be measured by a CT or MRI scan.
This is an investigational study. Imatinib mesylate is FDA approved and docetaxel are FDA approved for other types of cancer however their use together in this study is investigational. Dexamethasone is required to be given with docetaxel. All three drugs are commercially available. Up to 58 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate + Docetaxel | Experimental | Drug: Imatinib Mesylate, Drug: DocetaxelImatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A written, voluntary informed consent form must be completed prior to beginning any study procedure.
- Patients >/= 18 years of age.
- Histologically documented diagnosis of head and neck squamous cell cancer
- At least one measurable site of disease and can be assessed by Response Evaluation Criteria In Solid Tumors (RECIST).
- Performance status 0-2 (Eastern Cooperative Oncology Group, ECOG)
Key exclusion criteria (19 listed)
- Prior exposure to docetaxel or imatinib mesylate.
- Patient has received any other investigational agents within 30 days of first day of study drug dosing.
- Patients with myocardial infarction within the past 6 months or New York Heart Association class 3 or 4 congestive heart failure.
- Female patients who are pregnant or breast-feeding.
- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).
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 |
|---|---|---|
| Imatinib MesylateAlso: Gleevec, Imatinib, STI571400 mg by mouth daily | Drug | Imatinib Mesylate + Docetaxel |
| DocetaxelAlso: Taxotere60 mg/m^2 by vein (IV) over 1 hour every 3 weeks | Drug | Imatinib Mesylate + Docetaxel |
Primary outcome
Participant Response Rate
Time frame: At 6 weeks reconfirmed 6 weeks later
Response rate to regimen defined as the number of complete or partial response divided by the total number of participants treated. Tumor response defined by Response Evaluation Criteria In Solid Tumors (RECIST). All complete and partial responses confirmed by a second assessment six weeks later.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson 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.
Anne S. Tsao, MD principal investigator
M.D. Anderson Cancer Center
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 Imatinib Mesylate and Docetaxel in people with Head and Neck Cancer and Squamous Cell Cancer, run by M.D. Anderson Cancer Center 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 19 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 7 Aug 2012. 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 29 Aug 2011). 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?
Participant Response Rate (time frame: At 6 weeks reconfirmed 6 weeks later). 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 7 Aug 2012.