Small Cell Lung CancerPhase 2NCT00156286
Gleevec Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive Extensive SCLC
A Phase 2 study testing Gleevec in people with Small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Gleevec
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Apr 2006
- 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 extensive-stage SCLC, which is c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive pleural effusion.
- No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and irinotecan, at the dosages mentioned in the protocol, prior to registration can be registered on the trial if done so within 21 days after the start of the first cycle of chemotherapy. Prior palliative radiation therapy will be allowed as long as radiation was completed at least 2 weeks before starting protocol therapy.
- At least 18 years of age
- At least one uni-dimensionally measurable lesion or an evaluable outside the field of any prior radiation therapy.
- 5. Adequate organ function
- 6. Patients must sign informed consent that details the investigational nature of the study according to the institutional and federal guidelines.
Who cannot join
- Symptomatic or history of untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for 2 weeks after completion of appropriate therapy.
- Previous or concurrent malignancies, with the exception of adequately treated squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any other malignancy treated and in clinical remission for more than 3 years.
- Major surgery or radiation therapy within 2 weeks of enrollment.
- Peripheral neuropathy of NCI grade greater than 2.
- Symptomatic edema from any etiology.
- Therapeutic anticoagulation with warfarin. Patients can be eligible if they are changed from warfarin to low molecular weight heparin or heparin at least 2 weeks prior to starting Gleevec.
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- Serious concomitant medical illness, including, but not limited to, uncontrolled congestive cardiac failure, uncontrolled angina, myocardial infarction and/or stroke within 3 months, or HIV infection.
- Acute or chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
- History of dementia, active psychiatric disorder or any other condition, considered by the treating physician to impair the patient's ability to take oral pills on a daily basis or comply with the protocol requirements.
- Pregnant or lactating females. All pre-menopausal and peri-menopausal women should have a negative urine pregnancy test prior to enrollment. All patients, men and women, of reproductive potential should agree to use an effective contraceptive method for the duration of the trial and for 3 months after discontinuation of study treatment.
- Patients should not participate in other investigational agent study while taking part in this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The investigators also want to find out how the tumor is affected solely by induction therapy with irinotecan and cisplatin, what side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction followed by maintenance therapy) will improve the duration of survival
- Conditions
- Small Cell Lung Cancer
- Being tested
- Gleevec
- 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.
GleevecDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.
Secondary outcomes (1)
Clinical assessment, labs, and toxicity will be done weekly from weeks 2 through 8. Evaluation may be done more frequently after the first 8 weeks if required, but should be done at least every 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionJan 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Gregory Kalemkerian, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156286
- Sponsor's protocol ID
- UMCC 2001-066
- Other IDs
- Legacy IRB #2002-149
- Status last verified
- Nov 2010
- First submitted
- 7 Sep 2005
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Gleevec (Imatinib Mesylate, STI571) Maintenance Therapy After Induction Irinotecan and Cisplatin in Patients With C-Kit Positive, Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00156286
- Acronym / sponsor ID
- UMCC 2001-066
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 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.
This study involves being treated initially with a combination of drugs called irinotecan and cisplatin (induction therapy), followed by treatment with a drug called Gleevec (maintenance therapy). The main purpose of this study is to determine if this type of treatment will delay the growth of the tumor and if so, for how long. The investigators also want to find out how the tumor is affected solely by induction therapy with irinotecan and cisplatin, what side-effects occur when Gleevec maintenance therapy is used, and if this treatment (induction followed by maintenance therapy) will improve the duration of survival
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (6 listed)
- Histologically or cytologically confirmed extensive-stage SCLC, which is c-kit-positive by immunohistochemistry. Extensive-stage is defined as disease that extends beyond one hemithorax and regional lymph nodes (ipsilateral or contralateral hilar, mediastinal or supraclavicular lymph nodes), or with cytologically positive pleural effusion.
- No prior chemotherapy for SCLC. Patients who have started therapy with cisplatin and irinotecan, at the dosages mentioned in the protocol, prior to registration can be registered on the trial if done so within 21 days after the start of the first cycle of chemotherapy. Prior palliative radiation therapy will be allowed as long as radiation was completed at least 2 weeks before starting protocol therapy.
- At least 18 years of age
- At least one uni-dimensionally measurable lesion or an evaluable outside the field of any prior radiation therapy.
- 5. Adequate organ function
Key exclusion criteria (11 listed)
- Symptomatic or history of untreated brain or leptomeningeal metastases. Treated patients should be neurologically stable for 2 weeks after completion of appropriate therapy.
- Previous or concurrent malignancies, with the exception of adequately treated squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any other malignancy treated and in clinical remission for more than 3 years.
- Major surgery or radiation therapy within 2 weeks of enrollment.
- Peripheral neuropathy of NCI grade greater than 2.
- Symptomatic edema from any etiology.
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 | Drug | – |
Primary outcome
Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.
1 secondary outcome
Clinical assessment, labs, and toxicity will be done weekly from weeks 2 through 8. Evaluation may be done more frequently after the first 8 weeks if required, but should be done at least every 4 weeks.
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 16 Nov 2010.
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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.
Gregory Kalemkerian, M.D. principal investigator
University of Michigan Rogel Cancer Center
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 Gleevec in people with Small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center 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 6 inclusion and 11 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 16 Nov 2010. 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?
Tumor assessment should have been done within 28 days of starting Gleevec. Tumor assessment will be done every 8 weeks while on Gleevec.. 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 16 Nov 2010.