Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
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ClinicalTrials.gov Identifier: NCT01333696 |
Recruitment Status : Unknown
Verified March 2013 by Ye Guo, Fudan University.
Recruitment status was: Recruiting
First Posted : April 12, 2011
Last Update Posted : March 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Squamous Cell Carcinoma of Head and Neck | Drug: Pemetrexed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
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 |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | April 2013 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Pemetrexed
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
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Drug: Pemetrexed
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
Other Name: Alimta |
- Overall response rate [ Time Frame: 6 weeks ]
- Median progression-free survival [ Time Frame: 1 year ]
- Median overall survival [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01333696
Contact: Ye Guo, MD | 86 21 64175590 ext 8906 | pattrick_guo@msn.com |
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 |
Principal Investigator: | Ye Guo, MD | Fudan University |
Responsible Party: | Ye Guo, Dr., Fudan University |
ClinicalTrials.gov Identifier: | NCT01333696 |
Other Study ID Numbers: |
HNTG 11-01 |
First Posted: | April 12, 2011 Key Record Dates |
Last Update Posted: | March 5, 2013 |
Last Verified: | March 2013 |
Squamous cell carcinoma of head and neck Pemetrexed |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms |
Neoplasms by Site Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |