Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Imatinib mesylate; Paclitaxel
Intervention description: Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6; Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6
Intervention MeSH terms: Paclitaxel; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Lung cancer,; Non-small cell lung cancer; NSCLC; Metastatic; Gleevec; elderly

Summary:

      This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a
      PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients
      with advanced, non-small cell lung cancer.
    

Eligibility criteria:

        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
             edition.48

          -  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 intrauterine 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
             intercourse.

        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.