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

NCT01953419 | Completed Phase 2 DMC

• 1 other identifier: PEM001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  6 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

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

Drug: Pemetrexed disodium

Interventions

Pemetrexed disodium DRUG

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.

Also known as: LY-231514, brand name: Alimta

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen UniversityCancer center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• RH Xu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: October 1, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)