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Sponsors and Collaborators: |
Sun Yat-sen University Eli Lilly and Company |
Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00630149 |
This is a pilot phase II study of locally advanced or metastatic nasopharyngeal carcinoma (NPC) with the single drug Alimta. The objective of this study is to assess efficacy and safety profiles of Alimta as 2nd line treatment for patients with advanced NPC.
Condition | Intervention | Phase |
Nasopharyngeal Neoplasms |
Drug: Pemetrexed (Alimta) |
Phase II |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Pemetrexed disodium Pemetrexed Folic acid Vitamin B 12 Hydroxocobalamin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Open-Label Single-Arm Phase 2 Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Had Prior Platinum Based Chemotherapy |
Estimated Enrollment: | 66 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Pemetrexed (Alimta)
500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Li Zhang, Master | 86-20-8734-3458 | zhangli6@mail.sysu.edu.cn |
China, GuangDong | |||||
Cancer Center of Sun-Yat Sen University (CCSYSU) | Recruiting | ||||
GuangZhou, GuangDong, China, 510000 | |||||
Contact: Li Zhang, Master 86-20-8734-3458 zhangli6@mail.sysu.edu.cn |
Sun Yat-sen University |
Eli Lilly and Company |
Principal Investigator: | Li Zhang, Master | Cancer Center of Sun-Yat Sen University (CCSYSU) |
Responsible Party: | Cancer Center of Sun-Yat Sen University ( Li ZHANG ) |
Study ID Numbers: | H3E-GH-0034 |
First Received: | February 25, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00630149 |
Health Authority: | China: State Food and Drug Administration |
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