Olanzapine Improves the Chemotherapy Tolerance of Advanced Gastric Cancer

NCT03575637 | Unknown Phase 2

• 1 other identifier: Olanzapine
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Olanzapine; Gastric Cancer; Tolerance

Outcome Measures

Primary Outcomes (1)

• 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.

  2 year

Secondary Outcomes (2)

• side effect

  2 years

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

  2 years

Study Arms (2)

Olanzapine intervention group

EXPERIMENTAL

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

Drug: Olanzapine

Control group

NO INTERVENTION

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

Interventions

Olanzapine DRUG

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

Olanzapine intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shen Lin

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Lin

CONTACT

88156561; goodjf@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gastrointestinal oncology

Study Record Dates

• First Submitted: June 9, 2018
• First Posted: July 2, 2018
• Study Start: July 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)