Non-small Cell Lung CancerPhase 2NCT01083589
Imatinib Mesylate and Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Imatinib Mesylate and Docetaxel in people with Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how effective the combination of the drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell lung cancer (NSCLC). The safety and tolerability of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung 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
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jul 2011
- 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
- An written, voluntary informed consent form must be completed prior to beginning any study procedure.
- Patients >/= 18 years of age.
- Histologically documented diagnosis of non-small cell lung cancer.
- At least one measurable site of disease that is amenable to biopsy. Lesion must be at least 20 mm in the longest diameter by spiral computed tomography (CT) or 20 mm with conventional techniques according to RECIST. Lesion must not have been previously irradiated.
- Performance status 0-1 (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 limit of normal (ULN); (2) serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) < 2.5 * UNL; (3) creatinine < 1.5 * ULN; (4) ANC > 1.5 * 10^9/L; (5) platelets > 100 * 10^9/L.
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- 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 throughout the study and for up to 3 months following discontinuation of study drug.
- Patients who have received one prior systemic chemotherapy treatment (not including biologic agents e.g. gefitinib, lonafarnib).
- Patients who were originally diagnosed with earlier stage Non-small-cell lung carcinoma (NSCLC) \& were treated with curative intent (i.e. pts who have received induction chemotherapy (platinum-based doublet) prior to definitive radiation or surgery) but then develop recurrent or metastatic disease \& are then treated with a platinum-based doublet for frontline metastatic therapy are still eligible for this study. This is as long as they have not been exposed to docetaxel during any point of their therapy. Once patients have been diagnosed with metastatic or recurrent disease, they may only have received one platinum-based therapy.
Who cannot join
- Patient has received any other investigational agents within 30 days of first day of study drug dosing.
- 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.
- Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- 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).
- Patient has a known untreated or unstable brain metastasis.
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- Patient has known chronic liver disease (i.e., chronic active hepatitis, and 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.
- Prior exposure to imatinib mesylate.
- Prior exposure to docetaxel systemic therapy for this NSCLC malignancy.
- Patient treated with more than 1 prior systemic chemotherapy (not including biologic agents e.g. gefitinib, lonafarnib)
- Participation in an investigational trial within the past 30 days.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Imatinib Mesylate and Docetaxel in Pretreated Patients With Metastatic NSCLC
The goal of this clinical research study is to learn how effective the combination of the drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell lung cancer (NSCLC). The safety and tolerability of this drug combination will also be studied.
Read the detailed description
Imatinib mesylate is a medication that blocks certain proteins important in the development of cancer. Docetaxel is a drug that 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. Docetaxel will be given through a vein in your arm on the first day of each treatment cycle for a total of 6 cycles. The infusion will take 1 hour. A treatment cycle on this study is 21 days.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and hypersensitivity reactions. The dexamethasone will come in a pill form to be taken every 12 hours for 3 days starting the day before chemotherapy. You will also receive additional dexamethasone by vein before the docetaxel is given.
After you complete 6 treatment cycles, you will continue to take 4 imatinib mesylate tablets each day until your cancer gets worse, or you experience unacceptable side effects, or you withdraw from the study.
While on this study, you will have a physical exam every 3 weeks. During the first 5 weeks of the study, you will have blood tests each week. About 3 teaspoons of blood will be drawn each time. After the first 5 weeks, you will have blood tests (3 teaspoons each) at the beginning of each treatment cycle. In addition, your tumor will be measured by a CT or MRI scan every 6 weeks.
You must agree not to use herbal remedies or other over-the-counter therapies (e.g., shark cartilage) during treatment.
If you develop any unacceptable symptoms or changes in your laboratory tests, your treatment may be delayed and/or the dose decreased until the symptoms are gone. It may even be necessary to stop your treatment. Your doctor will inform you of any changes in your dosing schedule or in the doses of your medication after he/she evaluates you in the clinic.
After treatment ends, you will have a follow-up visit at the clinic. At this visit, you will have a complete physical exam, including blood (about 3 teaspoons) and urine tests. You will also have a CT scan to measure the size of the tumor in your body.
This is an investigational study. Imatinib mesylate is FDA approved for the treatment of leukemia. Docetaxel is FDA approved for the treatment of breast, prostate, and NSCLC. Up to 50 patients will take part in this study. All will be enrolled at UTMDACC.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Imatinib Mesylate, Docetaxel
- Keywords
- Lung Cancer, Metastatic NSCLC, Tumor, Imatinib Mesylate, Gleevec, Docetaxel, Taxotere
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Also called Imatinib, Gleevec, STI571, NSC-716051
Oral 400 mg daily
DocetaxelDrug
Also called Taxotere
60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib Mesylate + Docetaxel | Experimental | Imatinib Mesylate (Gleevec) Oral 400 mg daily + Docetaxel (Taxotere) 60 mg/m2 over 1 hour intravenous infusion repeated every 21 days. Receives: Drug: Imatinib Mesylate; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response Rate
Response rate to new regimen defined as the percentage of complete or partial response within the total number of patients treated. Treatment response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Measured: Baseline and with each 3 week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2005
- Primary completionOct 2007
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083589
- Sponsor's protocol ID
- 2004-0726
- Status last verified
- Jan 2012
- First submitted
- 8 Mar 2010
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 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 Pretreated Patients With Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT01083589
- Acronym / sponsor ID
- 2004-0726
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung Cancer, Metastatic NSCLC, Tumor, Imatinib Mesylate, Gleevec, Docetaxel, Taxotere
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Mar 2010 (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 goal of this clinical research study is to learn how effective the combination of the drugs imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) is in treating non-small cell lung cancer (NSCLC). The safety and tolerability of this drug combination will also be studied.
Detailed description
Imatinib mesylate is a medication that blocks certain proteins important in the development of cancer. Docetaxel is a drug that 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. Docetaxel will be given through a vein in your arm on the first day of each treatment cycle for a total of 6 cycles. The infusion will take 1 hour. A treatment cycle on this study is 21 days.
You will need to take steroids (dexamethasone) before receiving docetaxel to try to prevent fluid accumulation and hypersensitivity reactions. The dexamethasone will come in a pill form to be taken every 12 hours for 3 days starting the day before chemotherapy. You will also receive additional dexamethasone by vein before the docetaxel is given.
After you complete 6 treatment cycles, you will continue to take 4 imatinib mesylate tablets each day until your cancer gets worse, or you experience unacceptable side effects, or you withdraw from the study.
While on this study, you will have a physical exam every 3 weeks. During the first 5 weeks of the study, you will have blood tests each week. About 3 teaspoons of blood will be drawn each time. After the first 5 weeks, you will have blood tests (3 teaspoons each) at the beginning of each treatment cycle. In addition, your tumor will be measured by a CT or MRI scan every 6 weeks.
You must agree not to use herbal remedies or other over-the-counter therapies (e.g., shark cartilage) during treatment.
If you develop any unacceptable symptoms or changes in your laboratory tests, your treatment may be delayed and/or the dose decreased until the symptoms are gone. It may even be necessary to stop your treatment. Your doctor will inform you of any changes in your dosing schedule or in the doses of your medication after he/she evaluates you in the clinic.
After treatment ends, you will have a follow-up visit at the clinic. At this visit, you will have a complete physical exam, including blood (about 3 teaspoons) and urine tests. You will also have a CT scan to measure the size of the tumor in your body.
This is an investigational study. Imatinib mesylate is FDA approved for the treatment of leukemia. Docetaxel is FDA approved for the treatment of breast, prostate, and NSCLC. Up to 50 patients will take part in this study. All will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib Mesylate + Docetaxel | Experimental | Drug: Imatinib Mesylate, Drug: DocetaxelImatinib Mesylate (Gleevec) Oral 400 mg daily + Docetaxel (Taxotere) 60 mg/m2 over 1 hour intravenous infusion repeated every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- An written, voluntary informed consent form must be completed prior to beginning any study procedure.
- Patients >/= 18 years of age.
- Histologically documented diagnosis of non-small cell lung cancer.
- At least one measurable site of disease that is amenable to biopsy. Lesion must be at least 20 mm in the longest diameter by spiral computed tomography (CT) or 20 mm with conventional techniques according to RECIST. Lesion must not have been previously irradiated.
- Performance status 0-1 (Eastern Cooperative Oncology Group (ECOG))
Key exclusion criteria (21 listed)
- Patient has received any other investigational agents within 30 days of first day of study drug dosing.
- 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.
- Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- 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).
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: Imatinib, Gleevec, STI571, NSC-716051Oral 400 mg daily | Drug | Imatinib Mesylate + Docetaxel |
| DocetaxelAlso: Taxotere60 mg/m2 over 1 hour intravenous infusion repeated every 21 days. | Drug | Imatinib Mesylate + Docetaxel |
Primary outcome
Patient Response Rate
Time frame: Baseline and with each 3 week cycle
Response rate to new regimen defined as the percentage of complete or partial response within the total number of patients treated. Treatment response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
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 11 Jan 2012.
- UT MD Anderson Cancer Center websiteLink 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 study chair
UT MD 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 Non-small Cell Lung 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 9 inclusion and 21 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 11 Jan 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?
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?
Patient Response Rate (time frame: Baseline and with each 3 week cycle). 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 11 Jan 2012.