Lung CancerPhase 2NCT01654081
A Protocol of Irinotecan for Carcinoma of the Lung
A Phase 2 study testing Irinotecan in people with Lung Cancer, run by Susanne Arnold.
Trial summary
The goal of this trial is to demonstrate the potential clinical benefit of irinotecan chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of clinical benefit (objective response, disease… 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?
- Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2014
- 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
- Subjects must be 18 years of age or greater with histologically or cytologically confirmed non-small cell lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic or recurrent disease after at least one prior chemotherapy regimen
- Prior invasive malignancies are allowed, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol.
- All participants must have received at least one prior chemotherapy regimen for metastatic NSCLC; prior adjuvant or neoadjuvant chemotherapy for NSCLC will also be allowed, but will NOT be counted toward the number of regimens for metastatic disease unless patients develop evidence of metastatic disease within six months of the initiation of the adjuvant chemotherapy, indicating resistance to platinum-based therapy. There is no limit on the number of prior regimens allowed, provided the patient meets all other eligibility criteria. Patients who may best benefit from the application of specific targeted therapies (i.e., erlotinib for EGFR exon 19 or 21 activating mutations, or crizotinib for EML4-ALK translocations) will be eligible for this protocol only after documented progression through such targeted therapy AND a platinum-based doublet regimen
- All participants must have the appropriate phenotype on pretreatment screening of tumor tissue or sputa, consisting of ISG15-positive cells by immunohistochemistry (staining score of 4-12, as defined in section 4.2), performed by the UK Department of Pathology, and must agree to have their tissues evaluated for ISG15 expression (a separate informed consent will be requested). Potential participants who have no available tissue for assessment will be offered sputum assessment or tissue biopsy if it can be performed safely, potential disease sites can be safely approached, and only if it is the opinion or their attending physician that participation in this protocol represents their best treatment option at this time. Subjects with assessable material will not be required to undergo a separate biopsy solely for participation in this protocol.
- Subjects must have the following baseline laboratory values (bone marrow, renal, hepatic):
- Adequate bone marrow function:
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- Absolute neutrophil count >1000/μL
- Platelet count >100'000/μL
- Serum creatinine < 2.0 mg/dL
- Bilirubin <1.5x normal
- Serum calcium < 12 mg/dl
- Signed Informed Consent
- ECOG Performance Status <2
- Life expectancy > 16 weeks
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Patients of childbearing potential must be using an effective means of contraception.
- The effects of Irinotecan on the developing human fetus are unknown. For this reason and because camptothecins are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of irinotecan administration.
Who cannot join
- Prior therapy with irinotecan, topotecan, or other camptothecin analog
- Patients whose tumor harbors an EGFR exon 19 or 21 mutation who has not yet received prior therapy with an EGFR-specific tyrosine kinase inhibitor such as erlotinib or gefitinib
- Patients whose tumor harbors an EML4/ALK translocation and who has not yet received crizotinib
- Pregnant or lactating females
- Myocardial infarction or ischemia, or active cerebrovascular disease, within the 6 months before Cycle 1' Day 1
- Uncontrolled clinically significant dysrhythmia
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- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
- Uncontrolled metastatic disease of the central nervous system (previously treated, stable disease is allowable on this protocol)
- Radiotherapy within the 2 weeks before registration
- Surgery within the 2 weeks before registration
- Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
- Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients who are receiving any other investigational agents.
- Patients with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Pregnant women are excluded from this study because Irinotecan is a camptothecin with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Irinotecan, breastfeeding should be discontinued if the mother is treated with Irinotecan.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Irinotecan. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
About this study
Official title: A Non-randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced ISG15-positive Non-small Cell Carcinoma of the Lung
The goal of this trial is to demonstrate the potential clinical benefit of irinotecan chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of clinical benefit (objective response, disease stability, and time to progression) compared to historical controls that were not previously selected for ISG-15 expression.
- Conditions
- Lung Cancer
- Being tested
- Irinotecan
- Keywords
- Lung Cancer, POSITIVE NON SMALL CELL CARCINOMA, ISG15, IRINOTECAN
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan | Experimental | Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival following irinotecan therapy
Progression-free survival following irinotecan therapy
Measured: up to five years after initiation of protocol therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startOct 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Slow accrual
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Susanne Arnold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Arnold, University of Kentucky
- Investigators
- Susanne Arnold, M.D., Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654081
- Sponsor's protocol ID
- 11-LUN-90-MCC
- Status last verified
- May 2014
- First submitted
- 27 Jul 2012
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced ISG15-positive Non-small Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT01654081
- Acronym / sponsor ID
- 11-LUN-90-MCC
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, POSITIVE NON SMALL CELL CARCINOMA, ISG15, IRINOTECAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Susanne ArnoldUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Jul 2012 (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.
The goal of this trial is to demonstrate the potential clinical benefit of irinotecan chemotherapy in patients with a specific NSCLC phenotype, ISG15-positive. The use of irinotecan in subjects with ISG15-positive NSCLC will be associated with an improved rate of clinical benefit (objective response, disease stability, and time to progression) compared to historical controls that were not previously selected for ISG-15 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan | Experimental | Drug: IrinotecanIrinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must be 18 years of age or greater with histologically or cytologically confirmed non-small cell lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic or recurrent disease after at least one prior chemotherapy regimen
- Prior invasive malignancies are allowed, provided at least five years has elapsed since the completion of therapy and enrollment on this protocol.
- All participants must have received at least one prior chemotherapy regimen for metastatic NSCLC; prior adjuvant or neoadjuvant chemotherapy for NSCLC will also be allowed, but will NOT be counted toward the number of regimens for metastatic disease unless patients develop evidence of metastatic disease within six months of the initiation of the adjuvant chemotherapy, indicating resistance to platinum-based therapy. There is no limit on the number of prior regimens allowed, provided the patient meets all other eligibility criteria. Patients who may best benefit from the application of specific targeted therapies (i.e., erlotinib for EGFR exon 19 or 21 activating mutations, or crizotinib for EML4-ALK translocations) will be eligible for this protocol only after documented progression through such targeted therapy AND a platinum-based doublet regimen
- All participants must have the appropriate phenotype on pretreatment screening of tumor tissue or sputa, consisting of ISG15-positive cells by immunohistochemistry (staining score of 4-12, as defined in section 4.2), performed by the UK Department of Pathology, and must agree to have their tissues evaluated for ISG15 expression (a separate informed consent will be requested). Potential participants who have no available tissue for assessment will be offered sputum assessment or tissue biopsy if it can be performed safely, potential disease sites can be safely approached, and only if it is the opinion or their attending physician that participation in this protocol represents their best treatment option at this time. Subjects with assessable material will not be required to undergo a separate biopsy solely for participation in this protocol.
- Subjects must have the following baseline laboratory values (bone marrow, renal, hepatic):
Key exclusion criteria (16 listed)
- Prior therapy with irinotecan, topotecan, or other camptothecin analog
- Patients whose tumor harbors an EGFR exon 19 or 21 mutation who has not yet received prior therapy with an EGFR-specific tyrosine kinase inhibitor such as erlotinib or gefitinib
- Patients whose tumor harbors an EML4/ALK translocation and who has not yet received crizotinib
- Pregnant or lactating females
- Myocardial infarction or ischemia, or active cerebrovascular disease, within the 6 months before Cycle 1' Day 1
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 |
|---|---|---|
| IrinotecanIrinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle | Drug | Irinotecan |
Primary outcome
Progression-free survival following irinotecan therapy
Time frame: up to five years after initiation of protocol therapy
Progression-free survival following irinotecan therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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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.
Susanne Arnold, M.D. principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan in people with Lung Cancer, run by Susanne Arnold.
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 17 inclusion and 16 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: withdrawn, as of the sponsor's last update on 30 May 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 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 was withdrawn before enrolling participants, so there are no results.
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 following irinotecan therapy (time frame: up to five years after initiation of protocol therapy). 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 30 May 2014.