Extensive Stage Small Cell Lung CancerPhase 2NCT00470054
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
A Phase 2 study testing dasatinib in people with Extensive Stage Small Cell Lung Cancer and Limited Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- What is being tested?
- dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
- Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- Lesions that are not considered measurable include the following:
- Bone lesions
- Leptomeningeal disease
Show all 36Show fewer
- Ascites
- Pleural or pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area, unless progression after radiotherapy is documented in these lesions
- No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
- ECOG performance status 0-1
- Platelet count >= 100,000/mm^3
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
- AST =< 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- No significant cardiac disease, including any of the following:
- New York Heart Association class III-IV heart disease
- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- Prolonged QTc > 480 msec (Fridericia correction)
- Major conduction abnormality (unless a cardiac pacemaker is present)
- No more than 1 prior chemotherapy regimen
- No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
- At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
- At least 2 weeks since prior surgery and recovered
- At least 1 week since prior and no concurrent agents with proarrhythmic potential
- At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
- At least 1 week since prior and no concurrent grapefruit concentrate
- No concurrent palliative radiotherapy
- No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent chemotherapeutic or investigational agents
- Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer
This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.
III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.
- Conditions
- Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Being tested
- dasatinib
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dasatinibDrug
Also called BMS-354825, Sprycel
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (dasatinib) | Experimental | Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Week Progression Free Survival
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method.
Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
Measured: 6 weeks
Secondary outcomes (4)
Progression Free Survival (PFS)
PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.
Progression is defined as in the primary outcome measure.
Measured: Time from registration to progression (up to 3 years)
Response to Therapy
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:
- Complete Response (CR): disappearance of all target lesions;
- Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
- Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions;
- Stable Disease (SD): small changes that do not meet above criteria.
Measured: Assessed every 2 cycles (up to 3 years)
Overall Survival
Overall survival (OS) was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.
Measured: Time from registration to death (up to 3 years)
Number of Participants With Grade 3 or Higher Adverse Events
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 was used to evaluate toxicity.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.
Measured: Assessed during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionApr 2013
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 Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Antonius Miller, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470054
- Sponsor's protocol ID
- NCI-2009-00467
- Other IDs
- NCI-2009-00467, CDR0000543528, CALGB 30602, CALGB-30602, P30CA014236, U10CA031946
- Status last verified
- Jun 2014
- First submitted
- 3 May 2007
- Last updated
- 5 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00470054
- Acronym / sponsor ID
- NCI-2009-00467
- Conditions
- Extensive Stage Small Cell Lung Cancer, Limited Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Posted 26 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.
III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (dasatinib) | Experimental | Drug: dasatinibPatients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
- Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- Lesions that are not considered measurable include the following:
- No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| dasatinibAlso: BMS-354825, SprycelGiven PO | Drug | Treatment (dasatinib) |
Primary outcome
6 Week Progression Free Survival
Time frame: 6 weeks
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: Time from registration to progression (up to 3 years)
Response to Therapy
Time frame: Assessed every 2 cycles (up to 3 years)
Overall Survival
Time frame: Time from registration to death (up to 3 years)
Number of Participants With Grade 3 or Higher Adverse Events
Time frame: Assessed during treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- 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.
Antonius Miller principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dasatinib in people with Extensive Stage Small Cell Lung Cancer and Limited Stage Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 36 inclusion and 0 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 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Apr 2013). 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?
6 Week Progression Free Survival (time frame: 6 weeks). 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 5 May 2015.