Lung CancerPhase 2NCT00222144
Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer
A Phase 2 study testing Gleevec and Taxotere in people with Lung Cancer, run by University of Kansas at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Gleevec and Taxotere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
VA Medical Center
Kansas City, Missouri, 64128
About this study
Official title: Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Gleevec and Taxotere
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gleevec and TaxotereDrug
Also called Docetaxel, Imatinib
Gleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gleevec and Taxotere Receives: Drug: Gleevec and Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Every 2 cycles of therapy and followup
Secondary outcomes (1)
Time to progression, survival and correlation of PDGF and PDGFR with outcome.
Measured: Baseline, at completion of therapy, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Kansas Masonic Cancer Research Institute
- Responsible party
- Sponsor
- Investigators
- Chao H Huang, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222144
- Sponsor's protocol ID
- 9698
- Status last verified
- Aug 2012
- First submitted
- 13 Sep 2005
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gleevec and Taxotere in Recurrent Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00222144
- Acronym / sponsor ID
- 9698
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Novartis, Kansas Masonic Cancer Research Institute
- Study start
- Sep 2004
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gleevec and TaxotereGleevec and Taxotere |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gleevec and TaxotereAlso: Docetaxel, ImatinibGleevec 600 mg QD for 12 months Taxotere IV 30 mg/m2 on day 1, 8 and 15 | Drug | 1 |
Primary outcome
Response rate
Time frame: Every 2 cycles of therapy and followup
1 secondary outcome
Time to progression, survival and correlation of PDGF and PDGFR with outcome.
Time frame: Baseline, at completion of therapy, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao H Huang, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gleevec and Taxotere in people with Lung Cancer, run by University of Kansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Every 2 cycles of therapy and followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.