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Study Summary
No. 2004-0726:.......Lung......Anne S. Tsao......Thoracic and Head and Neck Med
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Study Summary Title
Study Summary
Number:
2004-0726
Study Title:Phase II study of imatinib mesylate and docetaxel in pretreated patients with metastatic NSCLC
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Physician New Patient Referral
Name:Anne S. TsaoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic and Head and Neck MedReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6363
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Return visits are scheduled every 3 weeks for up to 11 visits.
Treatment
Agents:
Docetaxel
Gleevec
Home Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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 NSCLC. The safety and tolerability of this drug combination will
also be studied.
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Study Objectives / Outcomes
Primary Objectives:

1. To determine the efficacy of the combination of imatinib mesylate and docetaxel in metastatic non-small cell lung cancer by serial measurements of tumor response (extent, frequency, duration).

Secondary Objectives:

1. To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with metastatic non-small cell lung cancer.
2. To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by
    a) histologic analysis of biopsy tissue with measurements of endothelial cell apoptosis
    b) by non-invasive assessments of tumor vascularity performed before, during and after treatment
    c) electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate
3. To explore the biologic effects of imatinib mesylate and docetaxel on serum biomarkers.
4. To assess the survival rate.
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Study Status Information
Study Activation / Registration Date:01/18/2005
IRB Review and Approval Date:11/03/2004
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 CT or 20 mm with conventional techniques according to RECIST. Lesion must not have been previously irradiated.

5) Performance status 0-1 (ECOG)

6) Patients must have adequate hepatic, renal, and bone marrow function, defined as the following: (1) total bilirubin < 1.5 x ULN; (2) SGOT and SGPT < 2.5 x UNL; (3) creatinine < 1.5 x ULN; (4) ANC > 1.5 x 10*9/L; (5) platelets > 100 x 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) Pts who were originally diagnosed w/ earlier stage NSCLC & were treated w/ curative intent (i.e. pts who have received induction chemotherapy (platinum-based doublet) prior to definative radiation or surgery) but then develop recurrent or metasatic disease & are then treated w/ 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 pts 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 cirrhosis).

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 trial.

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.

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Links
Registration Number: NCT01083589
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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