Lung CancerPhase 2NCT00248482
Imatinib Mesylate After Irinotecan and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Cisplatin, Gleevec™ and irinotecan in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Cisplatin, Gleevec™ and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2002to Jan 2008
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Extensive stage disease, defined by 1 of the following criteria:
- Disease extends beyond one hemithorax and regional lymph nodes
- Cytologically positive pleural effusion
- Meets 1 of the following criteria:
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside the field of any prior radiotherapy
- Evaluable disease
- No history of untreated or symptomatic brain or leptomeningeal metastases
- Prior brain metastases allowed provided patient is neurologically stable for 2 weeks after completion of therapy
PATIENT CHARACTERISTICS:
Performance status
- SWOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST and ALT ≤ 2.5 times ULN
- AP ≤ 5 times ULN AND AST and ALT normal
- No acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 65 mL/min
Cardiovascular
- No uncontrolled congestive heart failure
- No uncontrolled angina
- No myocardial infarction and/or stroke within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No symptomatic edema from any etiology
- No known HIV positivity
- No other serious medical illness
- No other malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- No history of dementia, active psychiatric disorder, or other condition that would preclude study compliance or ability to take oral medication on a daily basis
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy for SCLC
Endocrine therapy
- No concurrent routine systemic corticosteroids
Radiotherapy
- See Disease Characteristics
- At least 2 weeks since prior palliative radiotherapy
Surgery
- More than 2 weeks since prior major surgery
Other
- No concurrent therapeutic anticoagulation with warfarin
- Concurrent low molecular weight heparin allowed provided regimen was initiated ≥ 2 weeks prior to study entry
- No other concurrent participation in another study of an investigational agent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
- Determine the response rate in patients treated with irinotecan and cisplatin.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year.
After completion of study treatment, patients are followed for 4 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- Cisplatin, Gleevec™, irinotecan
- Keywords
- extensive stage small cell lung cancer, recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called Platinol ®, Platinol®-AQ, CDDP
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Gleevec™Drug
Also called STI-571, imatinib mesylate
Gleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease.
irinotecanDrug
Also called Camptosar®, Camptothecin-11, CPT-11
Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan, Cisplatin & Gleevec™ | Experimental | Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease.
Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles Receives: Drug: Cisplatin; Drug: Gleevec™; Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: at 4 months
Secondary outcomes (3)
Overall survival
Measured: at least 4 months after discontinuation of treatment
Tolerability of Gleevec maintenance therapy
Measured: 30 days after completion of study treatment
Response rate as measured by RECIST at
Measured: Baseline and every 8 weeks during study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startFeb 2002
- Primary completionApr 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Shirish M. Gadgeel, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248482
- Sponsor's protocol ID
- CDR0000445222
- Other IDs
- P30CA022453, WSU-C-2461, WSU-UMCC-2001-066, CST1571B US93
- Status last verified
- Apr 2013
- First submitted
- 3 Nov 2005
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00248482
- Acronym / sponsor ID
- CDR0000445222
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer, recurrent small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Novartis Pharmaceuticals
- Study start
- Feb 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 4 Nov 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.
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
- Determine the response rate in patients treated with irinotecan and cisplatin.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive irinotecan IV over 90 minutes on days 1 and 8 and cisplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response (partial or complete) or stable disease proceed to maintenance therapy.
- Maintenance therapy: Patients receive oral imatinib mesylate twice daily for 6 months in the absence of disease progression or unacceptable toxicity. Some patients may continue to receive therapy for up to 1 year.
After completion of study treatment, patients are followed for 4 months.
PROJECTED ACCRUAL: A total of 80 patients will be accrued 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 |
|---|---|---|
| Irinotecan, Cisplatin & Gleevec™ | Experimental | Drug: Cisplatin, Drug: Gleevec™, Drug: irinotecanCisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease. Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CisplatinAlso: Platinol ®, Platinol®-AQ, CDDPCisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles | Drug | Irinotecan, Cisplatin & Gleevec™ |
| Gleevec™Also: STI-571, imatinib mesylateGleevac 400 mg po BID (800mg/day)- fo patients with objective response or stable disease. | Drug | Irinotecan, Cisplatin & Gleevec™ |
| irinotecanAlso: Camptosar®, Camptothecin-11, CPT-11Irinotecan: 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles | Drug | Irinotecan, Cisplatin & Gleevec™ |
Primary outcome
Progression-free survival
Time frame: at 4 months
3 secondary outcomes
Overall survival
Time frame: at least 4 months after discontinuation of treatment
Tolerability of Gleevec maintenance therapy
Time frame: 30 days after completion of study treatment
Response rate as measured by RECIST at
Time frame: Baseline and every 8 weeks during study treatment
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 29 Apr 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.
Shirish M. Gadgeel, MD principal investigator
Barbara Ann Karmanos Cancer Institute
2 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 Cisplatin, Gleevec™ and irinotecan in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 2 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?
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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Progression-free survival (time frame: at 4 months). 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 29 Apr 2013.