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

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ClinicalTrials.gov Identifier: NCT01953419
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Pemetrexed disodium Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pemetrexed for Previously Treated Patients With Metastatic Gastric Cancer: a Prospective Phase II Study
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity
 Drug: Pemetrexed disodium
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.
Other Names:
  • LY-231514
  • brand name: Alimta


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histological confirmed inoperable or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
  2. age between 18 and 80 years
  3. ECOG performance status of 0 to 2
  4. life expectancy ≥ 12 weeks
  5. has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
  6. at least one prior chemotherapy regimen
  7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
  8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
  9. 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,
  10. 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:

  1. other primary malignancy
  2. symptomatic central nervous system metastasis
  3. pregnancy or lactation
  4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
  5. ongoing infection
  6. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953419


Locations
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China, Guangdong
Sun Yat-sen UniversityCancer center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: RH Xu Sun Yat-sen University
More Information
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Responsible Party: Ruihua Xu, Vice president, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01953419    
Other Study ID Numbers: PEM001
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors