Lung CancerPhase 2NCT00104754
Liposomal SN-38 in Treating Patients With Small Cell Lung Cancer
A Phase 2 study testing liposomal SN-38 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer. 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?
- liposomal SN-38
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 meeting 1 of the following criteria:
- Previously untreated disease
- Extensive stage disease, as defined by any of the following:
- Metastatic disease outside of the chest
- Contralateral supraclavicular or contralateral hilar nodes that cannot be included in a single radiation port
- Malignant pleural effusion
- Previously treated disease
- Limited or extensive stage disease
- Measurable disease
- Lesions ≥ 1 cm and < 2 cm must be measured by spiral CT scan for pre- and post-treatment tumor assessment
- UGT1A1*28 genotype wt/wt (6/6 promoter TA repeats) OR wt/*28 (6/7 promoter TA repeats)
- No *28/*28 (7/7 promoter TA repeats) genotype
- No mixed histology
- No uncontrolled CNS metastasis
- Previously treated, stable CNS metastasis allowed
- No superior vena cava syndrome
- No malignant pericardial effusion
- No near obstruction of the trachea or main stem bronchi
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Total bilirubin < 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
Renal
- Creatinine < 1.5 times ULN
Cardiovascular
- No unstable angina pectoris
- No uncontrolled congestive heart failure
- No myocardial infarction within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study participation
- No syndrome of inappropriate antidiuretic hormone secretion
- No ectopic adrenocorticotrophic syndrome
- No Lambert-Eaton myasthenic syndrome
- No other severe paraneoplastic syndrome
- No active infection requiring oral or parenteral antibiotics
- No other life threatening disease
- No other malignancy except basal cell or squamous cell skin cancer, localized prostate cancer, superficial bladder cancer, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF) during course 1 of study treatment
Chemotherapy
- No more than 1 prior chemotherapy regimen for this malignancy
- Prior cyclophosphamide, doxorubicin, and vincristine (CAV) alternating with etoposide and cisplatin (EP) allowed
- More than 21 days since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 14 days since prior radiotherapy
- Concurrent palliative radiotherapy allowed except radiotherapy to a solitary measured index lesion
Surgery
- More than 21 days since prior major surgery
Other
- No other concurrent treatment for this malignancy
- No other concurrent investigational treatment
About this study
Official title: Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with small cell lung cancer treated with SN-38 liposome that is dosed according to a UGT1A1-specific genotype.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, overall and progression-free survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients.
- Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since prior treatment).
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 73 patients (40 for stratum I and 33 for stratum II) will be accrued for this study within 16-19 months.
- Conditions
- Lung Cancer
- Being tested
- liposomal SN-38
- Keywords
- extensive stage small cell lung cancer, limited 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.
liposomal SN-38Drug
| Study group | Role | What they receive |
|---|---|---|
| liposomal SN-38 | Experimental | Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years. Receives: Drug: liposomal SN-38 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response measured by number of responses
Measured: Up to 3 years
Secondary outcomes (3)
Time to disease progression
Measured: Up to 3 years
Survival time
Measured: Up to 3 years
Change in quality of life (QOL) score over time
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 posted4 Mar 2005 (estimated)
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.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James R. Jett, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104754
- Sponsor's protocol ID
- NCCTG-N0322
- Other IDs
- CDR0000415847
- Status last verified
- Jul 2016
- First submitted
- 3 Mar 2005
- Last updated
- 20 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Liposome Encapsulated SN38 (LE-SN38) in the Treatment of Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00104754
- Acronym / sponsor ID
- NCCTG-N0322
- Conditions
- Lung Cancer
- Keywords
- 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
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 4 Mar 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: Drugs used in chemotherapy, such as liposomal SN-38, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well liposomal SN-38 works in treating patients with small cell lung cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with small cell lung cancer treated with SN-38 liposome that is dosed according to a UGT1A1-specific genotype.
- Determine the toxicity of this drug in these patients.
- Determine, preliminarily, overall and progression-free survival of patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
- Correlate UGT1A1-specific haplotypes with toxicity of this drug in these patients.
- Correlate UGT1A1-specific haplotypes with outcomes of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (previously untreated disease OR chemosensitive disease and ≥ 3 months since prior treatment vs refractory disease OR chemoresistant disease and < 3 months since prior treatment).
Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study.
Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 73 patients (40 for stratum I and 33 for stratum II) will be accrued for this study within 16-19 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal SN-38 | Experimental | Drug: liposomal SN-38Patients receive SN-38 liposome IV over 90 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response or patients with stable disease (SD) who were previously treated before study enrollment receive up to 4 additional courses of treatment. Patients with CNS-only disease progression receive whole brain radiotherapy (WBRT). After completion of WBRT, these patients also receive up to 4 additional courses of treatment. Patients with disease progression to sites other than the CNS or patients with SD who were previously untreated before study enrollment are removed from the study. Quality of life is assessed at baseline, before each treatment course, and then annually for 3 years. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years. |
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 |
|---|---|---|
| liposomal SN-38 | Drug | liposomal SN-38 |
Primary outcome
Tumor response measured by number of responses
Time frame: Up to 3 years
3 secondary outcomes
Time to disease progression
Time frame: Up to 3 years
Survival time
Time frame: Up to 3 years
Change in quality of life (QOL) score over time
Time frame: Up to 3 years
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 20 Jul 2016.
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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.
James R. Jett, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal SN-38 in people with Lung Cancer, run by Alliance for Clinical Trials in Oncology.
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: withdrawn, as of the sponsor's last update on 20 Jul 2016. 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?
Tumor response measured by number of responses (time frame: Up to 3 years). 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 20 Jul 2016.