Non-small Cell Lung CancerPhase 1/2NCT02127372
Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571
A Phase 1/2 study testing Docetaxel, Cisplatin and STI571, Docetaxel and Cisplatin in people with Non-small Cell Lung Cancer, run by Duke University.
Trial summary
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC). This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel, Cisplatin and STI571, Docetaxel and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Dec 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
- Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
- At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
- No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
- ECOG performance status 0-1.
- Meets initial laboratory parameters.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Who cannot join
- Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
- Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
- Patients with:
- Contrast allergy.
- GI bleed ≤ 1 month from study enrollment.
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- Intermittent or chronic oxygen requirements.
- Pulse oximetry <90%.
- Grade 3 dyspnea.
- History of poorly regulated anticoagulation with warfarin.
- Edema or fluid retention grade >1.
- Neuropathy grade ≥1.
- Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
- Psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months.
- Any type of hearing impairment.
- Known HIV infection.
- Receiving other investigational agents.
About this study
Official title: A Phase I - II Open Label Study of the Maximum Tolerated Dose, Safety and Efficacy of Docetaxel and Cisplatin Plus STI571 in Advanced Non-Small Cell Lung Cancer
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).
This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Cisplatin and STI571Drug
Also called Taxotere, Platinol, Gleevec, Imatinib
Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.
Phase 1 dose levels are:
- Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg
- Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg
- Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg
- Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg
- Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg
- Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg
Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II.
DocetaxelDrug
Also called Taxotere
CisplatinDrug
Also called Platinol
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Maximum Tolerated Dose (MTD) of STI571
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Measured: After cycle 1, day 22
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Measured: After cycle 1, day 22
Phase II - Radiographic Response
The percentage of patients with a complete or partial response.
Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:
Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measured: After Cycle 6, approximately 18 weeks.
Secondary outcomes (2)
Phase 2: 1 Year Survival
Phase II: Percentage of patients alive 1 year from the start of protocol treatment.
Measured: 1 year
Change in Gd-MRI Measurement
The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startNov 2004
- Primary completionJun 2010
- Study completionDec 2010
Why it stopped: The study was closed due to poor accrual
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.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordana Vlahovic, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127372
- Sponsor's protocol ID
- Pro00008205
- Status last verified
- Sep 2014
- First submitted
- 24 Apr 2014
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I - II Open Label Study of the Maximum Tolerated Dose, Safety and Efficacy of Docetaxel and Cisplatin Plus STI571 in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02127372
- Acronym / sponsor ID
- Pro00008205
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- non-small cell, lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to poor accrual
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).
This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
- Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
- At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
- No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
- ECOG performance status 0-1.
Key exclusion criteria (17 listed)
- Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
- Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
- Patients with:
- Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
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 |
|---|---|---|
| Docetaxel, Cisplatin and STI571Also: Taxotere, Platinol, Gleevec, ImatinibTreatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given. Phase 1 dose levels are: * Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg * Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg * Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg * Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg * Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg * Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II. | Drug | – |
| DocetaxelAlso: Taxotere | Drug | – |
| CisplatinAlso: Platinol | Drug | – |
Primary outcome
Phase 1 - Maximum Tolerated Dose (MTD) of STI571
Time frame: After cycle 1, day 22
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
Time frame: After cycle 1, day 22
To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.
Phase II - Radiographic Response
Time frame: After Cycle 6, approximately 18 weeks.
The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
2 secondary outcomes
Phase 2: 1 Year Survival
Time frame: 1 year
Change in Gd-MRI Measurement
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gordana Vlahovic, MD, MHS principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel, Cisplatin and STI571, Docetaxel and Cisplatin in people with Non-small Cell Lung Cancer, run by Duke University.
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 7 inclusion and 17 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: stopped early, as of the sponsor's last update on 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 15 Sep 2014). 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?
Phase 1 - Maximum Tolerated Dose (MTD) of STI571 (time frame: After cycle 1, day 22). The study lists 3 primary outcomes in all. 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 15 Sep 2014.