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Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

Phase 2
18 Years
Not Enrolling

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Trial Information

Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Shrinkage of tumor size and diameter of 3 respectively 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals


European Union: European Medicines Agency

Study ID:




Start Date:

September 2005

Completion Date:

Related Keywords:

  • Thymoma
  • Open label
  • phase II
  • disease
  • clinical trial
  • Octreotide
  • thymoma
  • cancer
  • tumor
  • Thymoma