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Trial record 60 of 2708 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

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ClinicalTrials.gov Identifier: NCT03289741
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Octreotide Drug: LAR Lanreotide Behavioral: Questionnaires Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Two-arm randomized design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study To Evaluate Patient Experience With the Somatostatin Analogs Octreotide Long Acting Release and Lanreotide During the Treatment of Advanced, Nonfunctional, Well Differentiated Neuroendocrine Tumors
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Octreotide then Lanreotide
Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections
Drug: Octreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections

Drug: LAR Lanreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

Behavioral: Questionnaires
Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.

Experimental: Lanreotide then Octreotide
Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
Drug: Octreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections

Drug: LAR Lanreotide
Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections

Behavioral: Questionnaires
Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.




Primary Outcome Measures :
  1. Comparison of mean pain scores [ Time Frame: 2 years ]
    Patients will rate, on a numeric scale of 0 to 10, with 0 being No pain" to 10 being "Worst pain ever" the pain or discomfort experienced with the SSA injection.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent for the trial
  • ≥ 18 years of age
  • Histologically- or cytologically- confirmed locally advanced or metastatic WDNET
  • SSA therapy is recommended by physician for disease management, and has not yet begun
  • ECOG performance status of 0, 1, or 2

Exclusion Criteria:

  • Currently participating in a study of an investigational agent
  • Prior chemotherapy, targeted small molecule therapy within 2 weeks prior to study Day 1 or not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent

    *Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study

  • No concurrent chemotherapy or targeted small molecule therapy
  • If received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study
  • Known additional malignancy that is progressing or requires active treatment
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289741


Contacts
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Contact: Nitya Raj, MD 646-888-4849 rajn@mskcc.org
Contact: Leonard Saltz, MD 646-888-4286

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nitya Raj, MD    646-888-4849      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nitya Raj, MD    646-888-4849      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nitya Raj, MD    646-888-4849      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Nitya Raj, MD    646-888-4849      
Memorial Sloan Kettering West Harrison Recruiting
Harrison, New York, United States, 10604
Contact: Nitya Raj, MD    646-888-4849      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nitya Raj, MD    646-888-4849      
Contact: Leonard Saltz, MD    646-888-4286      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Nitya Raj, MD    646-888-4849      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Nitya Raj, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03289741     History of Changes
Other Study ID Numbers: 17-422
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Octreotide
Lanreotide
17-422

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Octreotide
Lanreotide
Angiopeptin
Somatostatin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs