Recurrent Small Cell Lung CancerPhase 2NCT00052949
Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
A Phase 2 study testing imatinib mesylate and laboratory biomarker analysis in people with Recurrent Small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Small Cell Lung Cancer
- What is being tested?
- imatinib mesylate and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Oct 2007
- 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
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- No mixed histology
- Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
- c-Kit positive by immunohistochemistry (at least 1+)
- At least 1 unidimensionally measurable lesion
- Longest diameter at least 20 mm
Show all 30Show fewer
- No uncontrolled CNS metastasis
- Treated CNS metastasis allowed
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
- Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Direct bilirubin no greater than ULN
- Creatinine no greater than 1.5 times ULN
- No unstable angina pectoris
- No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
- No myocardial infarction within the past 3 months
- No uncontrolled infection
- No other malignancy within the past 3 years except skin cancer or localized prostate cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy
- More than 2 weeks since prior radiotherapy
- No concurrent radiotherapy(including palliative therapy for bone pain)
- Concurrent whole-brain radiotherapy for CNS progression allowed
- More than 3 weeks since prior major surgery
- No prior imatinib mesylate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Central Cancer Treatment Group
Rochester, Minnesota, 55905
About this study
Official title: Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity), pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to this drug with genetic differences in proteins involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior therapy (less than 3 months vs at least 3 months).
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
*Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.
NOTE: *Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy.
PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months for this study.
- Conditions
- Recurrent Small Cell Lung Cancer
- Being tested
- imatinib mesylate, laboratory biomarker analysis
- 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.
imatinib mesylateDrug
Given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity. Receives: Drug: imatinib mesylate; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients progression-free
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Measured: 16 weeks
Secondary outcomes (5)
Survival time
Estimated using the method of Kaplan-Meier.
Measured: From registration to death due to any cause, assessed up to 3 years
Time to disease progression
Estimated using the method of Kaplan-Meier.
Measured: From randomization to documentation of disease progression, assessed up to 3 years
Duration of response (complete response [CR] or partial response [PR])
Measured: The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
Time to treatment failure
Measured: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years
Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2003
- Primary completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cancer and Leukemia Group B
- Responsible party
- Sponsor
- Investigators
- Alex Adjei, Principal investigator, North Central Cancer Treatment Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052949
- Sponsor's protocol ID
- NCI-2012-01801
- Other IDs
- NCI-2012-01801, CDR0000269156, NCCTG-N0124, CALGB-30201, N0124, N0124, U10CA025224
- Status last verified
- Oct 2013
- First submitted
- 24 Jan 2003
- Last updated
- 8 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00052949
- Acronym / sponsor ID
- NCI-2012-01801
- Conditions
- Recurrent Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Collaborators
- Cancer and Leukemia Group B
- Study start
- May 2003
- Primary completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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.
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
Detailed description
PRIMARY OBJECTIVES:
- Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity), pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to this drug with genetic differences in proteins involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior therapy (less than 3 months vs at least 3 months).
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
*Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after registration.
NOTE: *Patients who develop CNS metastasis as the only site of disease progression receive therapeutic whole-brain radiotherapy and then resume study therapy.
PROJECTED ACCRUAL: A total of 41 patients for stratum I will be accrued within 21 months and 50 patients for stratum II will be accrued within 25 months for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate) | Experimental | Drug: imatinib mesylate, Other: laboratory biomarker analysisPatients receive oral imatinib mesylate twice daily for 28 days. Courses continue 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 (30 listed)
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
- c-Kit positive by immunohistochemistry (at least 1+)
- At least 1 unidimensionally measurable lesion
- No uncontrolled CNS metastasis
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 |
|---|---|---|
| imatinib mesylateGiven orally | Drug | Treatment (imatinib mesylate) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (imatinib mesylate) |
Primary outcome
The proportion of patients progression-free
Time frame: 16 weeks
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
5 secondary outcomes
Survival time
Time frame: From registration to death due to any cause, assessed up to 3 years
Time to disease progression
Time frame: From randomization to documentation of disease progression, assessed up to 3 years
Duration of response (complete response [CR] or partial response [PR])
Time frame: The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years
Time to treatment failure
Time frame: From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years
Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 3 years
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 8 Oct 2013.
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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.
Alex Adjei principal investigator
North Central Cancer Treatment Group
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 imatinib mesylate and laboratory biomarker analysis in people with Recurrent 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 30 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 8 Oct 2013. 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?
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?
The proportion of patients progression-free (time frame: 16 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 8 Oct 2013.