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Phase II Study of Imatinib Mesylate and Docetaxel in Pretreated Patients With Metastatic NSCLC

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer

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Trial Information

Phase II Study of Imatinib Mesylate and Docetaxel in Pretreated Patients With Metastatic NSCLC

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.

Inclusion Criteria:

1. An written, voluntary informed consent form must be completed prior to beginning any
study procedure.

2. Patients >/= 18 years of age.

3. Histologically documented diagnosis of non-small cell lung cancer.

4. 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

5. Performance status 0-1 (Eastern Cooperative Oncology Group (ECOG))

6. 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.

7. 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.

8. Patients who have received one prior systemic chemotherapy treatment (not including
biologic agents e.g. gefitinib, lonafarnib).

9. 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.

Exclusion Criteria:

1. Patient has received any other investigational agents within 30 days of first day of
study drug dosing.

2. 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.

3. 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)

4. Female patients who are pregnant or breast-feeding.

5. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection).

6. Patient has a known untreated or unstable brain metastasis.

7. Patient has known chronic liver disease (i.e., chronic active hepatitis, and

8. 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

9. Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C)
prior to study entry, unless the disease is rapidly progressing.

10. Patient previously received radiotherapy to >/= 25 % of the bone marrow

11. Patient had a major surgery within 2 weeks prior to study entry.

12. Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.

13. Patients must agree not to use herbal remedies or other over-the-counter biologics
(i.e. shark cartilage)

14. History of hypersensitivity to docetaxel or other taxane therapy.

15. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.

16. Prior exposure to imatinib mesylate.

17. Prior exposure to docetaxel systemic therapy for this NSCLC malignancy.

18. Patient treated with more than 1 prior systemic chemotherapy (not including biologic
agents e.g. gefitinib, lonafarnib)

19. Participation in an investigational trial within the past 30 days.

20. Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg
daily for catheter related anticoagulation are eligible for the study.

21. Prior pericardial effusion requiring intervention such as pericardiocentesis or
pericardial window.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response Rate

Outcome Description:

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.

Outcome Time Frame:

Baseline and with each 3 week cycle

Safety Issue:


Principal Investigator

Anne S. Tsao, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

July 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Metastatic NSCLC
  • Tumor
  • Imatinib Mesylate
  • Gleevec
  • Docetaxel
  • Taxotere
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030