177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01237457
• Date of registration: 08/11/2010
• Primary sponsor: Excel Diagnostics and Nuclear Oncology Center
• Public title: 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
• Scientific title: 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms
• Date of first enrolment: October 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01237457
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Susan Cork

• Name: Ebrahim S Delpassand, M.D
• Affiliation: Excel Diagnostics and Nuclear Oncology Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial
carcinoids)

- Presence of somatostatin-receptors on the known tumor lesions demonstrated by
OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The
uptake on the OctreoScan should be at least as high as normal liver uptake on planar
imaging.

- Life Expectancy greater than 12 weeks.

- Serum creatinine = 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance
(or measured GFR using plasma clearance methods, not gamma camera based) of =
50ML/min.

- Hemoglobin (Hgb) concentration = 5.5 mmol/L (= 8.9 g/dL); WBC = 2*109/L (2000/mm3);
platelets = 100*109/L (100*103/mm3).

- Total Bilirubin = 3X UNL.

- Serum Albumin > 30g/L or serum albumin = 30g/L but normal prothrombin time.

- All patients must have a Karnofsky performance status of at least 60%

- Patients must be greater than 18 years of age. Patients younger than 18 years will be
presented to FDA for compassionate use on a case by case basis

Exclusion Criteria:

- Possible surgery with curative intent.

- Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months
of the start of therapy.

- Patients with known brain metastases unless these metastases have been treated and
stabilized for at least 6 months prior to study start. Patients with a history of
brain metastases must have a head CT with contrast to document stable disease prior
to study start.

- Uncontrolled congestive heart failure.

- Any subject who is taking concomitant medications which decrease renal function (such
as aminoglycoside antibiotics).

- Any subject receiving therapy with somatostatin analogues, unless the dose has been
stable for at least 3 months prior to the first cycle in this study and the disease
status during these 3 months has been documented by modified RECISTS criteria as
described in this study

- Any subject receiving therapy with short acting somatostatin analogues in whom
these analogues cannot be interrupted for 12 hours before and 12 hours after the
administration of the radiolabelled somatostatin analogues, or any subject who
receives therapy with long-acting somatostatin analogues in whom these analogues
cannot be interrupted for at least 6 weeks before the administration of the
radiolabeled somatostatin analogues, unless the uptake on the Octreoscan during
continued somatostatin analogue medication is at least as high as normal liver uptake
on planar imaging.

- In patients with unusual hematological parameters, including an increased MCV
(>105fL), and especially in those who had previous chemotherapy, the advice of a
hematologist should be sought for adequate further work-up.

- Subjects with another significant medical, psychiatric, or surgical condition,
currently uncontrolled by treatment, which may interfere with completion of the
study.

- Prior radiation therapy to more than 25% of the bone marrow.

- Female patients who are pregnant, lactating or women of childbearing potential not
willing to practice effective contraceptive techniques during the study period and
for 60 days (10 half lives of 177Lu after the last treatment, or male patients who
have female partners of childbearing potential not willing to practice abstinence or
effective contraception, during the study period and for 60 days after the last
treatment



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Neuroendocrine Tumors

Intervention(s)

Drug: 177Lu-DOTATATE

Primary Outcome(s)

Progression Free survival [Time Frame: one year after completion of last treatment cycle]

Secondary Outcome(s)

Dose limiting toxicity [Time Frame: one year after completion of the fourth cycle of treatment]

Secondary ID(s)

78,256

Source(s) of Monetary Support

Please refer to primary and secondary sponsors