Small Cell Lung CancerPhase 2NCT01417806
Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung Cancer
A Phase 2 study testing Topotecan and Pasireotide in people with Small Cell Lung Cancer, run by South Florida Veterans Affairs Foundation for Research and Education at 1 site in United States.
Trial summary
The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. 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?
- Topotecan and Pasireotide
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2016
- 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 documented SCLC failed one chemotherapy with documentation of relapse or progressive disease.
- Measurable or evaluable disease by CT scan. If evaluable disease or measurable disease has been previously treated, this must show signs of tumor progression by CT.
- Karnofsky performance status of 80, Age ≥ 18 years and life expectancy of ≥12 weeks
- Minimum of four weeks since any major surgery, completion of radiation or chemotherapy
- ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hgb > 9 g/dL.
- Serum bilirubin ≤ 2 x upper limit of normal (ULN), and serum transaminases activity ≤ 3 x ULN, with the exception of serum transaminases (< 5 x ULN) if the patient has liver metastases. Serum creatinine ≤ 1.5 x ULN.
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- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. NOTE: If exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.
- Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
Who cannot join
- Prior topotecan or prior octreotide therapy.
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
- Uncontrolled brain or leptomeningeal metastases.
- Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other cancer from which the patient has been disease free for five years.
- Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN..
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- Patients with symptomatic cholelithiasis.
- Patients who have congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment.
- Patients who are at high risk for cardiac arrhythmias as defined by any of the following:
- Baseline QTcF > 450 msec
- History of syncope or family history of idiopathic sudden death or long QT syndrome
- Sustained or clinically significant cardiac arrhythmias
- Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high-grade AV block
- Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
- Concomitant medication(s) known to increase the QT interval
- Patients taking concomitant medications that are at risk of prolonging QT interval. If patient is to be included in the study, these medications need to be discontinued
- Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result
- None malignant disease that are uncontrolled such as severe impaired lung function.
- Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of pasireotide). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study.
- Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR formulation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA. Medical Center
Miami, Florida, 33125
Niramol Savaraj, M.D., 305-575-3143, nsavaraj@med.miami.edu
Vy Dinh, M.D., 305-575-3143, vdinh@med.miami.edu
About this study
Official title: A Phase II Trial of SOM230(PasireotideLAR) and Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer
The majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation. Topotecan is approved for second line therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents should yield greater antitumor activity.
Read the detailed description
The primary objectives of this study is to assess the progression-free survival (PFS) with the combination of SOM230 and topotecan in patients with SCLC who relapsed or progressed after front-line chemotherapy with cisplatin and etoposide. The secondary objective is to evaluate the efficacy and safety of SOM230 in combination with topotecan in this population. The primary end point is progression free survival. The secondary objective is response rate duration of response , overall survival , safety and tolerability. Patient who is eligible for the study will received topotecan 1.5mg/m2 on day 1-5 and SOM230 60mg on day 1 every 28 days until tumor progression or toxicity limit further treatment. Contrast-enhanced CT scans will be performed at baseline and every 2 months (or sooner if clinically indicated) to assess the response, duration of response, and time to tumor progression Patients will be allowed to remain on therapy if treatment is tolerated and if there is no evidence of progression for a maximum of 1 year or unacceptable toxicity occurs.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Topotecan and Pasireotide
- Keywords
- small cell lung cancer, somatostatin, topotecan
- 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.
Topotecan and PasireotideDrug
Topotecan 1.5mg/m2 dailyx5 days and Pasireotide 60 mg IM every 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Primary outcome Progression free survival (PFS).
Measured: 5 years
Secondary outcomes (1)
response rate and overall survival
Secondary outcome Response rate (RR), duration of response, overall survival (OS), safety and tolerability
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and Education
- Sponsor type
- US federal agency
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- Niramol Savaraj, M.D., Principal investigator, VA.Medical Center Miami, Fl. 33125
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417806
- Sponsor's protocol ID
- CSOM230DUS21T
- Status last verified
- Jul 2011
- First submitted
- 15 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SOM230(PasireotideLAR) and Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01417806
- Acronym / sponsor ID
- CSOM230DUS21T
- Conditions
- Small Cell Lung Cancer
- Keywords
- small cell lung cancer, somatostatin, topotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and EducationUS federal agency
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jul 2011
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Aug 2011 (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 majority of small cell lung cancer(SCLC)(50-100%) express somatostatin receptors(type 1-5) with some small cell lung cancer express more than one subtypes. Stimulation of these SSTR's lead to inhibition of angiogenesis and cell growth. SOM230 also lower levels of IGF which is known to contribute to SCLC proliferation. Topotecan is approved for second line therapy in relapsed small cell lung cancer. We hypothesized that combination of both agents should yield greater antitumor activity.
Detailed description
The primary objectives of this study is to assess the progression-free survival (PFS) with the combination of SOM230 and topotecan in patients with SCLC who relapsed or progressed after front-line chemotherapy with cisplatin and etoposide. The secondary objective is to evaluate the efficacy and safety of SOM230 in combination with topotecan in this population. The primary end point is progression free survival. The secondary objective is response rate duration of response , overall survival , safety and tolerability. Patient who is eligible for the study will received topotecan 1.5mg/m2 on day 1-5 and SOM230 60mg on day 1 every 28 days until tumor progression or toxicity limit further treatment. Contrast-enhanced CT scans will be performed at baseline and every 2 months (or sooner if clinically indicated) to assess the response, duration of response, and time to tumor progression Patients will be allowed to remain on therapy if treatment is tolerated and if there is no evidence of progression for a maximum of 1 year or unacceptable toxicity occurs.
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 (9 listed)
- Histologically documented SCLC failed one chemotherapy with documentation of relapse or progressive disease.
- Measurable or evaluable disease by CT scan. If evaluable disease or measurable disease has been previously treated, this must show signs of tumor progression by CT.
- Karnofsky performance status of 80, Age ≥ 18 years and life expectancy of ≥12 weeks
- Minimum of four weeks since any major surgery, completion of radiation or chemotherapy
- ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hgb > 9 g/dL.
Key exclusion criteria (20 listed)
- Prior topotecan or prior octreotide therapy.
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
- Uncontrolled brain or leptomeningeal metastases.
- Patients with prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other cancer from which the patient has been disease free for five years.
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 |
|---|---|---|
| Topotecan and PasireotideTopotecan 1.5mg/m2 dailyx5 days and Pasireotide 60 mg IM every 28 days | Drug | – |
Primary outcome
progression free survival
Time frame: 5 years
Primary outcome Progression free survival (PFS).
1 secondary outcome
response rate and overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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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.
Niramol Savaraj, M.D. principal investigator
VA.Medical Center Miami, Fl. 33125
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 Topotecan and Pasireotide in people with Small Cell Lung Cancer, run by South Florida Veterans Affairs Foundation for Research and Education 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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 16 Aug 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niramol Savaraj, M.D. (305-575-3143, nsavaraj@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 5 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 16 Aug 2011.