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

Arm | Intervention/treatment |
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Experimental: Treatment group
received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity
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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:
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- ORR [ Time Frame: 6 weeks ]

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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 |
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.

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
China, Guangdong | |
Sun Yat-sen UniversityCancer center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | RH Xu | Sun Yat-sen University |
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 |
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 |