Octreotide LAR as Maintenance Treatment for Patients With NEC
Primary Purpose
Gastro-entero-pancreatic Carcinoma, Esophageal Neuroendocrine Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Octreotide lar
Sponsored by
About this trial
This is an interventional treatment trial for Gastro-entero-pancreatic Carcinoma focused on measuring Octreotide LAR, Neuroendocrine carcinomas, unresectable or metastatic, Disease-free survival
Eligibility Criteria
Inclusion Criteria:
- Histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
- High grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded)
- Metastatic or unresectable disease
- Measurable disease
- Accepted chemotherapy with EP or IP regimen for no less than three months
- Effectiveness with CR/PR/SD
- Informed consent
- Performance status of 0 or 1
- Adequate bone marrow function (defined as absolute neutrophil count [ANC] >= 1500, platelet count [PLT] >= 75,000 and a hemoglobin [Hgb] >= 9).
- Adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <= 2.5 times the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then should be SGPT and SGOT <= 5 times the upper limits of normal.
Adequate renal function defined as serum creatinine <= 1.5 mg/dl.
Exclusion Criteria:
- Patients who are on EP or IP chemotherapy for less than three months .
- Effectiveness with PD.
- Patients with brain metastases are not eligible.
- Patients with New York Heart Association (NYHA) Class III or IV heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
- Pregnant or lactating women. All women of child bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
- Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
- Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
- Patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment.
- Patients with osseous metastasis as only site of disease.
- Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
- Patients with known Gilbert's syndrome are ineligible.
Sites / Locations
- Beijing Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
Octreotide LAR treatment
Arm Description
The patients with unresectable or metastatic GEP or esophageal NEC who got CR/PR/SD after chemotherapy with IP or EP regimen qualified with the inclusion criteria are enrolled. All the patients enrolled in our study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression.
Outcomes
Primary Outcome Measures
PFS
Secondary Outcome Measures
OS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02409849
Brief Title
Octreotide LAR as Maintenance Treatment for Patients With NEC
Official Title
Randomized Phase II Study of Octreotide LAR as Maintenance Treatment After First-line Chemotherapy for Patients With Unresectable or Metastatic Gastro-entero-pancreatic or Esophageal Neuroendocrine Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is phase II study on the efficacy of octreotide lar as maintenance treatment after first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.
Detailed Description
This is a prospective, randomized, open label study on the efficacy of octreotide lar as maintenance treatment after first-line chemotherapy for patients with unresectable or metastatic gastro-entero-pancreatic or esophageal neuroendocrine carcinomas.The patients with unresectable or metastatic GEP or esophageal NEC who got CR/PR/SD after chemotherapy with IP or EP regimen qualified with the inclusion criteria are enrolled. All the patients enrolled in our study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression. Treatment will be discontinued on withdrawal of patient consent, disease progression, unacceptable toxicity, a treatment delay of >2 weeks, or major protocol violations, after which patients were followed up every 3 months for a minimum of 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-entero-pancreatic Carcinoma, Esophageal Neuroendocrine Carcinoma
Keywords
Octreotide LAR, Neuroendocrine carcinomas, unresectable or metastatic, Disease-free survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
Octreotide LAR treatment
Arm Type
Experimental
Arm Description
The patients with unresectable or metastatic GEP or esophageal NEC who got CR/PR/SD after chemotherapy with IP or EP regimen qualified with the inclusion criteria are enrolled. All the patients enrolled in our study will be randomly assigned to receive octreotide LAR (group A) as maintenance treatment or follow up (group B) to disease progression.
Intervention Type
Drug
Intervention Name(s)
Octreotide lar
Other Intervention Name(s)
Octreotide lar 30mg,deep i.m,q28d,
Primary Outcome Measure Information:
Title
PFS
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic diagnosis of high grade (poorly differentiated) gastro-entero-pancreatic neuroendocrine carcinoma.
High grade neuroendocrine carcinoma of esophageal or unknown primary site (if a pulmonary primary has been excluded)
Metastatic or unresectable disease
Measurable disease
Accepted chemotherapy with EP or IP regimen for no less than three months
Effectiveness with CR/PR/SD
Informed consent
Performance status of 0 or 1
Adequate bone marrow function (defined as absolute neutrophil count [ANC] >= 1500, platelet count [PLT] >= 75,000 and a hemoglobin [Hgb] >= 9).
Adequate hepatic function with a bilirubin of <= 2.0 mg/dl, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) <= 2.5 times the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then should be SGPT and SGOT <= 5 times the upper limits of normal.
Adequate renal function defined as serum creatinine <= 1.5 mg/dl.
Exclusion Criteria:
Patients who are on EP or IP chemotherapy for less than three months .
Effectiveness with PD.
Patients with brain metastases are not eligible.
Patients with New York Heart Association (NYHA) Class III or IV heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
Pregnant or lactating women. All women of child bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
Patients with serum calcium > 12 mg/dl or symptomatic hypercalcemia under treatment.
Patients with osseous metastasis as only site of disease.
Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
Patients with known Gilbert's syndrome are ineligible.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, Prof
Phone
+86 10 88196175
Email
lin100@medmail.com.cn
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, Prof
Phone
+86 10 88196175
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Jie Li, Prof
12. IPD Sharing Statement
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Octreotide LAR as Maintenance Treatment for Patients With NEC
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