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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec and Taxotere
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center
  • VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Gleevec and Taxotere

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Time to progression, survival and correlation of PDGF and PDGFR with outcome.

Full Information

First Posted
September 13, 2005
Last Updated
August 6, 2012
Sponsor
University of Kansas
Collaborators
Novartis, Kansas Masonic Cancer Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00222144
Brief Title
Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer
Official Title
Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
Collaborators
Novartis, Kansas Masonic Cancer Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Gleevec and Taxotere
Intervention Type
Drug
Intervention Name(s)
Gleevec and Taxotere
Other Intervention Name(s)
Docetaxel, Imatinib
Intervention Description
Gleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Every 2 cycles of therapy and followup
Secondary Outcome Measure Information:
Title
Time to progression, survival and correlation of PDGF and PDGFR with outcome.
Time Frame
Baseline, at completion of therapy, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao H Huang, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States

12. IPD Sharing Statement

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

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