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

NCT01417806 | Unknown Phase 2 DMC

• 1 other identifier: CSOM230DUS21T
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; somatostatin; topotecan

Outcome Measures

Primary Outcomes (1)

• progression free survival

  Primary outcome Progression free survival (PFS).

  5 years

Secondary Outcomes (1)

• response rate and overall survival

  5 years

Interventions

Topotecan and Pasireotide DRUG

Topotecan 1.5mg/m2 dailyx5 days and Pasireotide 60 mg IM every 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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..
• 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

Sponsors & Collaborators

• South Florida Veterans Affairs Foundation for Research and Education: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

VA. Medical Center

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan; pasireotide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Niramol Savaraj, M.D.

  VA.Medical Center Miami, Fl. 33125

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niramol Savaraj, M.D.

CONTACT

305-575-3143; nsavaraj@med.miami.edu

Vy Dinh, M.D.

CONTACT

305-575-3143; vdinh@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 16, 2011

Record last verified: 2011-07

Locations

US (1)