Trial of pasireotideLAR and Topotecan in Relapsed or Refractory Small Cell Lung Cancer

Phase 2

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT01417806
• Lead Sponsor: South Florida Veterans Affairs Foundation for Research and Education

Brief 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. 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 Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Last Update Submitted: 2011-08-15
• Study First Posted: 2011-08-16
• Last Update Posted: 2011-08-16
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
progression free survival	5 years	Primary outcome Progression free survival (PFS).

Secondary Outcome Measures

Name	Time	Method
response rate and overall survival	5 years	Secondary outcome Response rate (RR), duration of response, overall survival (OS), safety and tolerability

Trial Locations

Locations (1)

VA. Medical Center; 🇺🇸 Miami, Florida, United States