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A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

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

Thank you

Trial Information

A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Inclusion Criteria:

- Age ≥ 70 years

- Histologic or cytologic diagnosis of non-small cell lung cancer

- At least one site of measurable disease, as defined by the modified RECIST criteria
(See section 7.6)

- Stage IIIB with pleural effusion or Stage IV disease. Includes patients who received
surgery alone for early stage disease, now in relapse with advanced disease. Staging
is according to the American Joint Committee on Cancer classification scheme, 6th

- Adequate hepatic, renal and marrow function

- Liver function tests: total bilirubin < 1.25 x upper limit of normal (ULN), AST
and ALT < 2.5 x ULN, Creatinine < 1.5 x ULN

- Baseline absolute neutrophil count > 1500/μL

- Baseline platelet count > 100,000/μL

- ECOG Performance Status 0, 1 or 2 at the time of informed consent. (See Appendix 1)

- Written, voluntary consent

- Patients with reproductive potential must use an acceptable contraceptive method.
Such methods include: 1) Male hormonal contraception; 2) Partner without reproductive
potential, including post-menopausal status or history of tubal ligation; 3) Partner
with ntrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral
contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5)
Routine use of barrier method, such as condoms or diaphragm, during sexual

Exclusion Criteria:

Uncontrolled brain metastasis. Patients with known brain metastasis must have completed
treatment with surgery, radiation or both. In addition, they must be off corticosteroids.

- Symptomatic neuropathy (Grade 2 or higher)

- Prior chemotherapy for advanced non-small cell lung cancer. (Prior adjuvant,
neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months
elapsed prior to documented metastatic recurrence.)

- Patient is < 5 years free of another primary malignancy, except: a) if the other
malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other
primary malignancy is not considered clinically significant and is requiring no
active intervention

- Prior radiation therapy to > 25% of bone marrow

- Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial
infarction within 6 months.

- Any serious or uncontrolled concomitant disorder that, in the opinion of the
investigator, would compromise the patient's ability to complete the study.

- Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis
or cirrhosis.

- Major surgery two weeks prior to study treatment

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

- Any condition requiring continuous administration of systemic corticosteroids.

- The patient is on therapeutic anti-coagulation with warfarin.

Type of Study:


Study Design:

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

Outcome Measure:

To estimate the clinical efficacy of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Julie Bauman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

July 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • avanced non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerque, New Mexico  87102