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Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the response rate of Gleevec with Taxotere in
patients with recurrent non-small cell lung cancer. Also to determine the expression of
PDGF-R, phosphorylated PDGF-r and C-kit in the original tissue and correlate with response.
If the patient has a tumor in an accessible location, we will ask for consent from the
patient to obtain biopsy before and after the therapy to assess the same molecular markers.

Inclusion Criteria:

- One prior chemotherapy treatment: use of single chemotherapy or a regimen containing
more than one drug. Regimen must have a platinum agent (cisplatin or carboplatin).
Prior biological treatment won't be counted as chemotherapy treatment.
Chemoradiation or prior induction or adjuvant chemotherapy +/- chemoradiation will
constitute one prior chemotherapy regimen. Patients may not have received Docetaxel.
Taxol as part of initial therapy is allowed.

- Documented recurrent/progressive disease by radiographic exam (CT scan, MRI, bone
scan or CXR), clinical exam (presence of palpable nodes) or biopsy.

- No signs of clinically active brain metastasis or spinal cord compression. If
patient has brain metastasis or cord compression, patient will be eligible if stable
without deterioration of performance status after radiation therapy and off

- Cases with pleural effusion must have another site of disease for measurement and

- ECOG performance status 0-1

- Bi-dimensional measurable disease (≥ 1 cm by CT or other radiogram; physical exam
alone is permissible if there is no radiographically measurable tumor)

- Laboratory: ANC ≥ 1,500/mm3, Hemoglobin > 8g/dl, platelet ≥ 100,000/mm3, Total
Bilirubin ≤ 1.5 mg/dl, Creatinine ≤ 2.0 mg/dl, Transaminase (AST/ALT) ≤ 2.5 X upper
normal limit if ALK phosphatase is ≤ Upper normal limit OR ALK may be up to 4X ULN if
transaminase are ≤ ULN.

- Age ≥ 18 years old

- Histologic or cytologic diagnosis of NSCLC, biopsy at diagnosis or on recurrence.
Histology may include large cell, squamous cell, undifferentiated, bronchioalveolar
or adenocarcinoma but not small cell lung cancer or mixed small and non-small cell
lung cancer, or carcinoid. Mixed histology non-small cell lung cancer will be
allowed, i.e.: large cell neuroendocrine carcinoma.

- IHC of the biopsy specimen, if available, for PDGF-R. Insufficient tissue will not
preclude study enrollment.

- FEV1>800 cc

Exclusion Criteria:

- ECOG performance status 2 or worse

- Psychological, familial, sociological or geographical conditions, which prevent
weekly medical follow-up or compliance with the study protocol

- Radiation to more than 30% of bone marrow

- More than 1 different prior cytotoxic chemotherapy regimen

- Co-Morbid condition that would affect survival: grade III/IV cardiac problems as
defined by New York Heart Association (e.g. end-stage congestive heart failure,
myocardial infarction within 6 months of study), random uncontrolled blood sugar ≥300
mg/dl, unstable angina, active infection on antibiotics, FEV1 less than 800 cc,
patient with known chronic liver disease (i.e., chronic active hepatitis and

- Use of investigational agents or chemotherapy within 4 weeks

- Pregnant or nursing women and women or men with reproductive potential unless using
effective contraception throughout study and for 3 months after discontinuation of
study drug.

- No other active invasive cancer. Patient is < 5 years free of another malignancy
except for: other primary malignancy isn't currently clinically significant or
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.

- Patients with a history of hypersensitivity to taxane, Polysorbate 80 or gemcitabine
and who could not tolerate treatment even with 24 H premedication with Decadron and
Benadryl. (If the patient had prior hypersensitivity, but did not receive 24 H
premedication for taxane, the patient may be eligible if he/she tolerates one cycle
with 24 H premedication).

- Existing peripheral neuropathy CTC Version 3> grade 2

- Patient has known diagnosis of human immunodeficiency virus (HIV) infection

- Patients who can not take oral medication. Percutaneous gastrostomy feeding tube
will be allowed if Gleevec can be given through PEG

- Patient who had major surgery within 2 weeks prior to study entry

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

Every 2 cycles of therapy and followup

Safety Issue:


Principal Investigator

Chao H Huang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

September 2004

Completion Date:

November 2010

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353
VA Medical Center Kansas City, Missouri  64128