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Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Olanzapine

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Olanzapine, Gastric Cancer, Tolerance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sign written informed consent;
Age more than 18 years of age;
Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
Locally advanced recurrent or metastatic disease;
Have received systemic first-line chemotherapy and confirmed first-line treatment failure (platinum combined with fluorouracils);
Subjects' baseline blood routine and biochemical indicators meet the following criteria Hemoglobin ≥90g/L The absolute neutrophil count (ANC) is ≥1.5×10^9/L. Platelets ≥100×10^9/L ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastasis) ALP≤2.5 times normal upper limit, ≤ 5 times normal upper limit (with liver or bone metastases) Serum total bilirubin <1.5 times normal upper limit Serum creatinine <1.5 times normal upper limit Serum albumin ≥30g/L
KPS score ≥ 60 points;
Life expectancy ≥ 3 months.

Exclusion Criteria:

Does not meet the above selection criteria;
The first-line treatment uses paclitaxel-based drugs;
Pregnancy and lactation women;
Allergies to research drugs or people with metabolic disorders;
History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
Those who have been receiving systemic steroids for a long period of time (Note: Short-term users may be discontinued >2 weeks for inclusion);
Brain metastasis;
With severe infections need treatment;
Accompanied by dysphagia active peptic ulcer complete or incomplete intestinal obstruction active gastrointestinal bleeding perforation etc;
Severe liver diseases (such as liver cirrhosis etc.) kidney disease respiratory diseases or chronic diseases such as diabetes high blood pressure that cannot be controlled;
Having other malignant tumors within 5 years except non-melanoma skin cancer and cervical cancer in situ;
Heart disease with markedly abnormal electrocardiogram or clinical symptoms such as congestive heart failure marked coronary heart disease uncontrolled arrhythmia high blood pressure or previous myocardial infarction within 12 months or cardiac function Class III or IV.

Sites / Locations

Peking University Cancer Hospital & InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Olanzapine intervention group

Control group

Arm Description

Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD.

Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen.

Outcomes

Primary Outcome Measures

time to treatment failure

From randomization to exit the trial, the reasons for withdrawal may be patients' refusal, disease progression, patient death, and adverse events etc.

Secondary Outcome Measures

side effect

Incidence of nausea and vomiting; Weight change; Drug exposure; Drug cumulative dose.

Progression free survival time (PFS), overall survival time (OS).

Full Information

NCT ID

NCT03575637

First Posted

June 9, 2018

Last Updated

July 2, 2018

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT03575637

Brief Title

Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer

Official Title

Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer: a Prospective Randomized Controlled Phase II Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2018 (Anticipated)

Primary Completion Date

May 2021 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To explore whether adding olanzapine to paclitaxel chemotherapy could improve chemotherapy tolerance and improve patient quality of life and prolong treatment failure time (TTF) in advanced gastric cancer after failure of first-line chemotherapy. This is a multi-center prospective randomized controlled open clinical study. Patients will formally be enrolled after they had been screened and signed informed consent. Baseline examinations will be started after entry into the group. Those who meet the criteria for inclusion and exclusion were dynamically randomized at 1: 1. The experimental group will receive olanzapine and paclitaxel until treatment failure and the control group will receive paclitaxel until treatment failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Olanzapine, Gastric Cancer, Tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine intervention group

Arm Type

Experimental

Arm Description

Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen.

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD.

Primary Outcome Measure Information:

Title

time to treatment failure

Description

From randomization to exit the trial, the reasons for withdrawal may be patients' refusal, disease progression, patient death, and adverse events etc.

Time Frame

2 year

Secondary Outcome Measure Information:

Title

side effect

Description

Incidence of nausea and vomiting; Weight change; Drug exposure; Drug cumulative dose.

Time Frame

2 years

Title

Progression free survival time (PFS), overall survival time (OS).

Description

Progression free survival time (PFS), overall survival time (OS).

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign written informed consent; Age more than 18 years of age; Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction; Locally advanced recurrent or metastatic disease; Have received systemic first-line chemotherapy and confirmed first-line treatment failure (platinum combined with fluorouracils); Subjects' baseline blood routine and biochemical indicators meet the following criteria Hemoglobin ≥90g/L The absolute neutrophil count (ANC) is ≥1.5×10^9/L. Platelets ≥100×10^9/L ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastasis) ALP≤2.5 times normal upper limit, ≤ 5 times normal upper limit (with liver or bone metastases) Serum total bilirubin <1.5 times normal upper limit Serum creatinine <1.5 times normal upper limit Serum albumin ≥30g/L KPS score ≥ 60 points; Life expectancy ≥ 3 months. Exclusion Criteria: Does not meet the above selection criteria; The first-line treatment uses paclitaxel-based drugs; Pregnancy and lactation women; Allergies to research drugs or people with metabolic disorders; History of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); Those who have been receiving systemic steroids for a long period of time (Note: Short-term users may be discontinued >2 weeks for inclusion); Brain metastasis; With severe infections need treatment; Accompanied by dysphagia active peptic ulcer complete or incomplete intestinal obstruction active gastrointestinal bleeding perforation etc; Severe liver diseases (such as liver cirrhosis etc.) kidney disease respiratory diseases or chronic diseases such as diabetes high blood pressure that cannot be controlled; Having other malignant tumors within 5 years except non-melanoma skin cancer and cervical cancer in situ; Heart disease with markedly abnormal electrocardiogram or clinical symptoms such as congestive heart failure marked coronary heart disease uncontrolled arrhythmia high blood pressure or previous myocardial infarction within 12 months or cardiac function Class III or IV.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shen Lin

Phone

88156561

goodjf@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shen Lin

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital & Institute

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shen Lin

12. IPD Sharing Statement

Plan to Share IPD

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Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer

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