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


Phase 2
70 Years
N/A
Not Enrolling
Both
Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of the combination of weekly paclitaxel and intermittent
imatinib in elderly patients with advanced non-small cell lung cancer.

II. To collect paraffin tissue blocks for a companion project evaluating the expression of
platelet derived growth factor (PDGF) by original tumor specimens, and its relationship to
response rate and survival.

OUTLINE:

Patients receive paclitaxel intravenously (IV) on days 3, 10, and 17 and imatinib mesylate
orally (PO) once daily (QD) on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days
for 4-6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.


Inclusion Criteria:



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

- At least one site of measurable disease, as defined by the modified RECIST criteria

- 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

- Total bilirubin < 1.25 x upper limit of normal (ULN)

- Baseline absolute neutrophil count >= 1500/uL

- Baseline platelet count >= 100,000/uL

- ECOG Performance Status 0, 1 or 2 at the time of informed consent

- 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

- AST and ALT =< 2.5 x ULN

- Creatinine =< 1.5 x ULN

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

- The administration of any other anticancer agents including chemotherapy and biologic
agents is NOT permitted

- The use of other concurrent investigational drugs is not allowed

- Participants in this study must avoid grapefruit juice or other grapefruit-containing
products for the duration of treatment with imatinib

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate (complete and partial responses) as assessed by RECIST criteria

Outcome Time Frame:

Baseline, Week 4 of courses 2, 4 and 6

Safety Issue:

No

Principal Investigator

Renato Martins

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6137

NCT ID:

NCT00408460

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Malignant Pleural Effusion
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636