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Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Ye Guo, Fudan University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Fudan University
Information provided by (Responsible Party):
Ye Guo, Fudan University
ClinicalTrials.gov Identifier:
NCT01333696
First received: April 11, 2011
Last updated: March 2, 2013
Last verified: March 2013
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Purpose
The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.
| Condition | Intervention | Phase |
|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Drug: Pemetrexed | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck |
Resource links provided by NLM:
Further study details as provided by Ye Guo, Fudan University:
Primary Outcome Measures:
- Overall response rate [ Time Frame: 6 weeks ]
Secondary Outcome Measures:
- Median progression-free survival [ Time Frame: 1 year ]
- Median overall survival [ Time Frame: 1 year ]
| Estimated Enrollment: | 32 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pemetrexed
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
|
Drug: Pemetrexed
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Other Name: Alimta
|
Detailed Description:
The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age range: 18-65 years old
- Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
- Prior exposure of at least one line of platinum-containing regimen
- At least one site of measurable disease according to RECIST criteria
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
- Liver function: total bilirubin, ALT and AST <1.5×UNL
- Renal function: Cr<1.5×UNL, CCR≧45ml/min
Exclusion Criteria:
- With curable treatment option
- Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Significant active infection
- Pregnant or lactating women
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333696
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333696
Contacts
| Contact: Ye Guo, MD | 86 21 64175590 ext 8906 | pattrick_guo@msn.com |
Locations
| China | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Ye Guo, MD 86 21 64175590 ext 8906 pattrick_guo@msn.com | |
| Principal Investigator: Ye Guo, MD | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Ye Guo, MD | Fudan University |
More Information
| Responsible Party: | Ye Guo, Dr., Fudan University |
| ClinicalTrials.gov Identifier: | NCT01333696 History of Changes |
| Other Study ID Numbers: |
HNTG 11-01 |
| Study First Received: | April 11, 2011 |
| Last Updated: | March 2, 2013 |
Keywords provided by Ye Guo, Fudan University:
|
Squamous cell carcinoma of head and neck Pemetrexed |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Neoplasms by Site Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 20, 2017