P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

NCT01886287 | Terminated Phase 2 Results

• 2 other identifiers: MCC-17410CSMS995AUS64T
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing, diarrhea, and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR.

Conditions

Neuroendocrine Carcinoma

Keywords

endocrine system; neuroendocrine tumors; neuroendocrine cancer; metastatic; neuroendocrine; gastrointestinal (GI); high-dose octreotide; flushing; diarrhea; quality of life in patients; disease-related symptoms

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improved Frequency of Diarrhea

  The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.

  At 12 weeks

Secondary Outcomes (1)

• Rate of Progression Free Survival (PFS) at 6 Months

  At 6 months

Study Arms (1)

Octreotide Long-acting Release (LAR)

EXPERIMENTAL

Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.

Drug: Octreotide LAR

Interventions

Octreotide LAR DRUG

Octreotide LAR as outlined in Treatment Arm.

Also known as: Sandostatin LAR®

Octreotide Long-acting Release (LAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic neuroendocrine tumors that are considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
• Elevated urine 5-hydroxyindoleacetic acid (5-HIAA)
• More than 2 bowel-movements per day OR more than 4 flushing episodes per week on average
• Patient currently on octreotide LAR 30mg every 3 or 4 weeks (for at least 3 cycles prior to screening)
• Age ≥ 18 years
• Minimum of four weeks since any major surgery, liver-directed therapy (embolization, etc.) or systemic cancer treatment other than octreotide LAR
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Life expectancy \> 12 weeks
• Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation.
• Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.

You may not qualify if:

• Known hypersensitivity to somatostatin analogues
• Patients with poorly differentiated neuroendocrine cancers
• Patients with liver cirrhosis
• Patients receiving hemodialysis or peritoneal dialysis
• Patients with cachexia who, in the opinion of the investigator, may have difficulty tolerating intramuscular injection
• Patients with symptomatic cholelithiasis or biliary events within past five years (who have not undergone cholecystectomy)
• Patients with recent history (within 5 years) of pancreatitis
• Patients with uncontrolled diabetes (HgA1c \>8.0 despite adequate therapy)
• Women of child-bearing potential, UNLESS they are using two birth control methods
• Women who are pregnant or lactating
• HIV positive patients
• History of sustained ventricular tachycardia, ventricular fibrillation, advanced heart block, idiopathic syncope thought to be related to ventricular arrhythmia, or congenital long QT syndrome
• Risk factors for Torsades de Pointes such as cardiac failure, clinically significant/symptomatic bradycardia
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• History of noncompliance to medical regimens or unwillingness to comply with the protocol

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Novartis: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neoplasm Metastasis; Flushing; Diarrhea

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Limitations and Caveats

This study was closed early due to slow accrual. There were no evaluable participants at 6 months for the planned Progression Free Survival measure.

Results Point of Contact

• Title: Jonathan Strosberg, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

jonathan.strosberg@moffitt.org

813-745-7257

Study Officials

• Jonathan Strosberg, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: June 25, 2013
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 12, 2015
• Results First Posted: January 12, 2015

Record last verified: 2015-01

Locations

US (1)