Squamous Cell Carcinoma of Head and NeckPhase 2NCT01333696
Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck
A Phase 2 study testing Pemetrexed in people with Squamous Cell Carcinoma of Head and Neck, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Ye Guo, MD, 86 21 64175590 ext. 8906, pattrick_guo@msn.com
Ye Guo, MD
About this study
Official title: Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- Pemetrexed
- Keywords
- Squamous cell carcinoma of head and neck, Pemetrexed
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta
Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed | Experimental | 500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 6 weeks
Secondary outcomes (2)
Median progression-free survival
Measured: 1 year
Median overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ye Guo, Fudan University
- Investigators
- Ye Guo, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333696
- Sponsor's protocol ID
- HNTG 11-01
- Status last verified
- Mar 2013
- First submitted
- 11 Apr 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
- ClinicalTrials.gov ID
- NCT01333696
- Acronym / sponsor ID
- HNTG 11-01
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Squamous cell carcinoma of head and neck, Pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed | Experimental | Drug: Pemetrexed500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: AlimtaPemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks | Drug | Pemetrexed |
Primary outcome
Overall response rate
Time frame: 6 weeks
2 secondary outcomes
Median progression-free survival
Time frame: 1 year
Median overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Guo, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed in people with Squamous Cell Carcinoma of Head and Neck, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Guo, MD (86 21 64175590 ext. 8906, pattrick_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.