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A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide AutogelĀ® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome


Phase 3
18 Years
N/A
Not Enrolling
Both
Malignant Carcinoid Syndrome

Thank you

Trial Information

A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide AutogelĀ® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome


Inclusion Criteria:



- Histologically confirmed diagnosis of a neuroendocrine tumor of the carcinoid type.

- Documented evidence of carcinoid syndrome (flushing and/or diarrhea) attributable to
a primary tumor of the lung, stomach or mid-gut.

- Previous positive Octreoscan.

- World Health Organization (WHO) performance score lower than 2.

At the baseline visit patients MUST satisfy the following criteria before they are
randomized to receive study treatment:

- Stool and/or flushing frequency of greater than or equal to 3 episodes/day (average
over a minimum five consecutive days).

- Patients who have previously been treated with somatostatin analogues must have
discontinued treatment for a sufficient period of time (a washout period of at least
7 days for immediate release formulations and up to 2 months for prolonged release
formulations is usually required). Compared with their "controlled" state on
treatment, these patients must show a clinically significant deterioration (at least
two episodes) of either symptom. For example, a patient considered to be controlled
on their previous treatment with an estimated stool frequency of two episodes per
day, must achieve a stool frequency of at least four episodes per day (average over a
minimum five consecutive days).

- WHO performance score lower than 2.

Exclusion Criteria:

- VIPoma or other non-carcinoid tumor.

- Treatment with interferon, chemotherapy or radiotherapy given within 30 days prior to
inclusion, or planned during the study.

- Radionuclide treatment within three months prior to inclusion, or planned during the
study.

- Presence of other active malignant pathology (except basal cellular carcinoma of the
skin and/or in situ carcinoma of the cervix/uterus).

- Surgical procedure or embolization procedure (with or without cytotoxic agents) of
the tumor within three months prior to inclusion, or planned during the study.

- Life expectancy of less than 6 months.

- Any investigational drug given within 30 days prior to inclusion or expected to be
given during the study.

- No access to a telephone for completion of the daily telephone diary.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Target symptom frequency (flushing or stool frequency).

Principal Investigator

France Catus, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United States: Food and Drug Administration

Study ID:

2-47-52030-722

NCT ID:

NCT00092287

Start Date:

July 2004

Completion Date:

October 2004

Related Keywords:

  • Malignant Carcinoid Syndrome
  • Carcinoid Syndrome
  • Neuroendocrine Tumuors
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

Name

Location

Larry Kvols, MDTampa, Florida  33612