Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Gleevec, paclitaxel
  • Each 28-day cycle includes three weekly doses of intravenous paclitaxel, administered on Day 3,10, and 17. Each 28-day cycle includes 12 daily doses of oral Gleevec (imatinib mesylate). Imatinib is administered in four-day pulses. Pulses bracket each paclitaxel infusion as follows: Days 1-4, Days 8-11, Days15-18. Each imatinib dose is 600 mg.

Primary Measures

• To estimate the clinical efficacy of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer.
  • Time Frame: 6 months
    Safety Issue?: Yes

Secondary Measures

• To evaluate the safety profile of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer.
  • Time Frame: 6 months
    Safety Issue?: Yes

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 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 70 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: New Mexico Cancer Care Alliance Other

Overall Clinical Trial Officials and Contacts

Julie Bauman, MD Principal Investigator University of New Mexico  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01011075

Study ID Number: INST CST1571BUS240

ClinicalTrials.gov Identifier: NCT01011075

Health Authority: United States: Institutional Review Board