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

This study has been completed.
Sponsor:
Collaborators:
Novartis
Kansas Masonic Cancer Research Institute
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00222144
First received: September 13, 2005
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

The primary goal of this study is to determine the effects of the combination of Gleevec and Taxotere in lung cancer in terms of control and reduction of the cancer size. The study will also test lung cancer to see if the presence of certain protein called receptor for platelet derived growth factor can influence the effect of the treatment.


Condition Intervention Phase
Lung Cancer
Drug: Gleevec and Taxotere
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Response rate [ Time Frame: Every 2 cycles of therapy and followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression, survival and correlation of PDGF and PDGFR with outcome. [ Time Frame: Baseline, at completion of therapy, 12 months ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 2004
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gleevec and Taxotere
Drug: Gleevec and Taxotere
Gleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15
Other Names:
  • Docetaxel
  • Imatinib

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 corticosteroids.
  • Cases with pleural effusion must have another site of disease for measurement and follow-up.
  • 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 cirrhosis)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222144

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
VA Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
University of Kansas
Novartis
Kansas Masonic Cancer Research Institute
Investigators
Principal Investigator: Chao H Huang, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00222144     History of Changes
Other Study ID Numbers: 9698
Study First Received: September 13, 2005
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014