Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00332969
First received: June 1, 2006
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.


Condition Intervention Phase
Thymoma
Drug: Octreotide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Shrinkage of tumor size and diameter of 3 respectively 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resection status after 3 respectively 6 months [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2005
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sandostatin Drug: Octreotide

  Eligibility

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

Inclusion Criteria:

  1. Male or female patients aged >18 years
  2. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
  3. Positive result in SMS-szintigraphy,
  4. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
  5. Patients with and without thymoma associated paraneoplastic syndrome
  6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

Exclusion Criteria:

  1. Performance status 0,1, or 2 (ECOG)
  2. Symptomatic cholelithiasis,
  3. Pretreatment with octreotide (longn acting release) within the 3 months
  4. Patient has received any other investigational agents within 28 days of first day of study drug dosing
  5. Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
  6. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)

Other protocol-defined inclusion/exclusion criteria apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332969

Locations
Germany
Novartis Investigative Site
Regensburg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00332969     History of Changes
Other Study ID Numbers: CSMS995ADE13
Study First Received: June 1, 2006
Last Updated: November 23, 2011
Health Authority: European Union: European Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Open label
phase II
disease
clinical trial
Octreotide
thymoma
cancer
tumor

Additional relevant MeSH terms:
Thymoma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014