Non-small Cell Lung CancerPhase 26137pNCT01011075
Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Imatinib mesylate and Paclitaxel in people with Non-small Cell Lung Cancer, run by New Mexico Cancer Research Alliance at 3 sites in United States.
Trial summary
This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Imatinib mesylate and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years
- Histologic or cytologic diagnosis of non-small cell lung cancer
- At least one site of measurable disease, as defined by the modified RECIST criteria (See section 7.6)
- 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.48
- Adequate hepatic, renal and marrow function
- Liver function tests: total bilirubin < 1.25 x upper limit of normal (ULN), AST and ALT < 2.5 x ULN, Creatinine < 1.5 x ULN
Show all 11Show fewer
- Baseline absolute neutrophil count > 1500/μL
- Baseline platelet count > 100,000/μL
- ECOG Performance Status 0, 1 or 2 at the time of informed consent. (See Appendix 1)
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Univ. of Washington Fred Hutchinson Cancer Research Center (UW-FHCRC)
Seattle, Washington, 98109-1024
About this study
Official title: A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.
Read the detailed description
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Imatinib mesylate, Paclitaxel
- Keywords
- Lung cancer,, Non-small cell lung cancer, NSCLC, Metastatic, Gleevec, elderly
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib mesylateDrug
Also called Gleevec
Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
PaclitaxelDrug
Also called Taxol
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6
| Study group | Role | What they receive |
|---|---|---|
| Imatinib mesylate + Paclitaxel | Experimental | Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6 Receives: Drug: Imatinib mesylate; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.
Measured: 6 months
Secondary outcomes (3)
Overall Survival
Overall survival as measured by the Kaplan-Meier method
Measured: 12 Months
Progression Free Survival
Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)
Measured: 12 months
Toxicities
Adverse events of grade 3 or higher, according to CTCAE version 3
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Novartis
- Responsible party
- Sponsor
- Investigators
- Julie Bauman, MD, Principal investigator, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011075
- Sponsor's protocol ID
- INST CST1571BUS240
- Other IDs
- NCI-2011-02947, 6137p
- Acronym
- 6137p
- Status last verified
- Jun 2015
- First submitted
- 14 Oct 2009
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bauman JE, Eaton KD, Wallace SG, Carr LL, Lee SJ, Jones DV, Arias-Pulido H, Cerilli LA, Martins RG. A Phase II study of pulse dose imatinib mesylate and weekly paclitaxel in patients aged 70 and over with advanced non-small cell lung cancer. BMC Cancer. 2012 Oct 3;12:449. doi: 10.1186/1471-2407-12-449.
PubMed 23033932
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01011075
- Acronym / sponsor ID
- 6137p / INST CST1571BUS240
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Lung cancer,, Non-small cell lung cancer, NSCLC, Metastatic, Gleevec, elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Novartis
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 3 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical efficacy of combining Gleevec (imatinib mesylate), a PDGFR antagonist, with front-line, single-agent paclitaxel in a cohort of elderly patients with advanced, non-small cell lung cancer.
Detailed description
Paclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib mesylate + Paclitaxel | Experimental | Drug: Imatinib mesylate, Drug: PaclitaxelPaclitaxel 90 mg/m2 IV on days 3, 10, 17 Imatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses bracketing each paclitaxel infusion (days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥ 70 years
- Histologic or cytologic diagnosis of non-small cell lung cancer
- At least one site of measurable disease, as defined by the modified RECIST criteria (See section 7.6)
- 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.48
- Adequate hepatic, renal and marrow function
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Imatinib mesylateAlso: GleevecImatinib (Gleevec) 600 mg/day, oral administration in 4-day pulses(days 1-4; 8-11; 15-18) Cycle length: 28 days Number of cycles: up to 6 | Drug | Imatinib mesylate + Paclitaxel |
| PaclitaxelAlso: TaxolPaclitaxel 90 mg/m2 IV on days 3, 10, 17 Cycle length: 28 days Number of cycles: up to 6 | Drug | Imatinib mesylate + Paclitaxel |
Primary outcome
Response Rate
Time frame: 6 months
Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.
3 secondary outcomes
Overall Survival
Time frame: 12 Months
Progression Free Survival
Time frame: 12 months
Toxicities
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23033932Bauman JE, Eaton KD, Wallace SG, Carr LL, Lee SJ, Jones DV, Arias-Pulido H, Cerilli LA, Martins RG. A Phase II study of pulse dose imatinib mesylate and weekly paclitaxel in patients aged 70 and over with advanced non-small cell lung cancer. BMC Cancer. 2012 Oct 3;12:449. doi: 10.1186/1471-2407-12-449.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Julie Bauman, MD principal investigator
University of New Mexico Cancer Center
3 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 Imatinib mesylate and Paclitaxel in people with Non-small Cell Lung Cancer, run by New Mexico Cancer Research Alliance at 3 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 12 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 3 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011075, which also lists 1 linked publication.
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 3 Jul 2015.