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

This study is currently recruiting participants.
Verified July 2011 by South Florida Veterans Affairs Foundation for Research and Education
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
South Florida Veterans Affairs Foundation for Research and Education
ClinicalTrials.gov Identifier:
NCT01417806
First received: August 15, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Topotecan and Pasireotide
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by South Florida Veterans Affairs Foundation for Research and Education:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Primary outcome Progression free survival (PFS).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 28
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)
Intervention Details:
    Drug: Topotecan and Pasireotide
    Topotecan 1.5mg/m2 dailyx5 days and Pasireotide 60 mg IM every 28 days
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Histologically documented SCLC failed one chemotherapy with documentation of relapse or progressive disease.
  2. 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.
  3. Karnofsky performance status of 80, Age ≥ 18 years and life expectancy of ≥12 weeks
  4. Minimum of four weeks since any major surgery, completion of radiation or chemotherapy
  5. ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hgb > 9 g/dL.
  6. 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.
  7. 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.
  8. 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.
  9. 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.

Exclusion criteria

  1. Prior topotecan or prior octreotide therapy.
  2. Chronic treatment with systemic steroids or another immunosuppressive agent.
  3. Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
  4. Uncontrolled brain or leptomeningeal metastases.
  5. 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.
  6. Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 1.5 ULN..
  7. Patients with symptomatic cholelithiasis.
  8. 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.
  9. 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
  10. 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
  11. 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
  12. None malignant disease that are uncontrolled such as severe impaired lung function.
  13. 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.
  14. Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR formulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417806

Contacts
Contact: Niramol Savaraj, M.D. 305-575-3143 nsavaraj@med.miami.edu
Contact: Vy Dinh, M.D. 305-575-3143 vdinh@med.miami.edu

Locations
United States, Florida
VA. Medical Center Recruiting
Miami, Florida, United States, 33125
Contact: Niramol Savaraj, M.D.    305-575-3143    nsavaraj@med.miami.edu   
Contact: Vy Dinh, M.D.    305-575-3143    vdinh@med.miami.edu   
Principal Investigator: Niramol Savaraj, M.D.         
Sponsors and Collaborators
South Florida Veterans Affairs Foundation for Research and Education
Novartis Pharmaceuticals
Investigators
Principal Investigator: Niramol Savaraj, M.D. VA.Medical Center Miami, Fl. 33125
  More Information

No publications provided

Responsible Party: Niramol Savaraj, M.D. Lucy Chua M.D. Vy Dinh M.D. Medhi Wangpaichits PhD, VA. Medical Center, Miami, Fl
ClinicalTrials.gov Identifier: NCT01417806     History of Changes
Other Study ID Numbers: CSOM230DUS21T
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by South Florida Veterans Affairs Foundation for Research and Education:
small cell lung cancer
somatostatin
topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014