Trial of pasireotideLAR and Topotecan in 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of SOM230(PasireotideLAR) and Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer|
- progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Primary outcome Progression free survival (PFS).
- response rate and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Secondary outcome Response rate (RR), duration of response, overall survival (OS), safety and tolerability
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Drug: Topotecan and Pasireotide
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.
|Contact: Niramol Savaraj, M.D.||email@example.com|
|Contact: Vy Dinh, M.D.||firstname.lastname@example.org|
|United States, Florida|
|VA. Medical Center||Recruiting|
|Miami, Florida, United States, 33125|
|Contact: Niramol Savaraj, M.D. 305-575-3143 email@example.com|
|Contact: Vy Dinh, M.D. 305-575-3143 firstname.lastname@example.org|
|Principal Investigator: Niramol Savaraj, M.D.|
|Principal Investigator:||Niramol Savaraj, M.D.||VA.Medical Center Miami, Fl. 33125|