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Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pemetrexed disodium

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
age between 18 and 80 years
ECOG performance status of 0 to 2
life expectancy ≥ 12 weeks
has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
at least one prior chemotherapy regimen
adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

Exclusion Criteria:

other primary malignancy
symptomatic central nervous system metastasis
pregnancy or lactation
cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
ongoing infection
inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.

Sites / Locations

Sun Yat-sen UniversityCancer center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity

Outcomes

Primary Outcome Measures

ORR

Secondary Outcome Measures

Full Information

NCT ID

NCT01953419

First Posted

August 12, 2013

Last Updated

July 26, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01953419

Brief Title

Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy

Official Title

Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.

Detailed Description

Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the presence of progressive disease or unacceptable toxicity. All patients took dexamethasone 3.75 mg twice daily, starting from the day before and continuing to the day after the drug administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy.Patients received Vitamin B12 very 3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be used when the patients suffered from bone marrow depression.

6. Conditions and Keywords

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

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

Pemetrexed disodium

Other Intervention Name(s)

LY-231514, brand name: Alimta

Intervention Description

Patients received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy. Patients received vitamin B12 before the first cycle of Pemetrexed and every three cycles of chemotherapy.

Primary Outcome Measure Information:

Title

ORR

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction age between 18 and 80 years ECOG performance status of 0 to 2 life expectancy ≥ 12 weeks has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) at least one prior chemotherapy regimen adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min, adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN. Exclusion Criteria: other primary malignancy symptomatic central nervous system metastasis pregnancy or lactation cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure ongoing infection inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs for 2 days before and after pemetrexed administration unwillingness to take folic acid or vitamin B12 supplementation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RH Xu

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen UniversityCancer center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy

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