Nasopharyngeal NeoplasmsPhase 2NCT00630149
Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy
A Phase 2 study testing Pemetrexed (Alimta) in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- Pemetrexed (Alimta)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of nasopharyngeal carcinoma.
- Locally recurrent or metastatic disease.
- Patients must have previously received one platinum based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- Prior platinum based chemotherapy completed at least 3 months prior to study enrollment and the patient must have recovered from toxic effects of the treatment.
- Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
- Disease status must be that of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
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- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Estimated life expectancy of at least 8 weeks.
- Patient compliance and geographic proximity that allow adequate follow-up.
- Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) >or= 1.5x10^9/L, platelets >or= 100x10^9/L, hemoglobin >or= 9g/dL. Hepatic: bilirubin <1.5 x ULN, alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 x ULN (alkaline phosphatase, AST, ALT < 5 x ULN is acceptable if liver has tumor involvement). Renal: calculated creatinine clearance > 45 ml/min.
- Men or women of at least 18 years of age.
- For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating. For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period.
- Signed informed consent from patient.
Who cannot join
- Known or suspected brain metastasis. Patients who have clinical signs or symptoms that are suspicious of brain metastasis must have a pretreatment computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. A patient with documented brain metastasis, at the time of consideration for study entry or in the past, will be excluded from entering in the study.
- Have previously completed or withdrawn from this study, or received Alimta previously outside this study.
- Concurrent administration of any other tumor therapy.
- Active infection (at the discretion of the investigator).
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Pregnancy or breast feeding.
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- History of significant neurological or mental disorder, including seizures or dementia.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of Alimta. If a patient is taking a NSAID (Cox-2 inhibitors included) or salicylate with a long half-life, it should not be taken 5 days before, the day of, and 2 days after the dose of Alimta.
- Presence of clinically relevant third-space fluid collections that cannot be controlled by drainage or other procedures prior to study entry.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Center of Sun-Yat Sen University (CCSYSU)
Guangzhou, Guangdong, 510000
About this study
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
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.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- Pemetrexed (Alimta)
- Keywords
- Nasopharyngeal Neoplasms, Pemetrexed
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed (Alimta)Drug
Also called Alimta
500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pemetrexed (Alimta) |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: Jan 2010
Secondary outcomes (5)
progression-free survival
Measured: Jan 2010
overall survival
Measured: Jan 2010
safety profile of pemetrexed (Alimta) treatment
Measured: Jan 2010
pharmacokinetic analysis of half-life, maximum plasma concentration (Cpmax), clearance (CL), area under the curve (AUC), and apparent volume of distribution
Measured: Jan 2010
evaluate the relationship between the expression of alpha folate receptor protein, TS and clinical response
Measured: Jan 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Master, Principal investigator, Cancer Center of Sun-Yat Sen University (CCSYSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630149
- Sponsor's protocol ID
- H3E-GH-0034
- Status last verified
- Feb 2012
- First submitted
- 25 Feb 2008
- Last updated
- 16 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00630149
- Acronym / sponsor ID
- H3E-GH-0034
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- Nasopharyngeal Neoplasms, Pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Mar 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pemetrexed (Alimta) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologic diagnosis of nasopharyngeal carcinoma.
- Locally recurrent or metastatic disease.
- Patients must have previously received one platinum based chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- Prior platinum based chemotherapy completed at least 3 months prior to study enrollment and the patient must have recovered from toxic effects of the treatment.
- Previous radiation therapy is allowed, but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Key exclusion criteria (12 listed)
- Known or suspected brain metastasis. Patients who have clinical signs or symptoms that are suspicious of brain metastasis must have a pretreatment computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. A patient with documented brain metastasis, at the time of consideration for study entry or in the past, will be excluded from entering in the study.
- Have previously completed or withdrawn from this study, or received Alimta previously outside this study.
- Concurrent administration of any other tumor therapy.
- Active infection (at the discretion of the investigator).
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
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 |
|---|---|---|
| Pemetrexed (Alimta)Also: Alimta500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation. | Drug | 1 |
Primary outcome
response rate
Time frame: Jan 2010
5 secondary outcomes
progression-free survival
Time frame: Jan 2010
overall survival
Time frame: Jan 2010
safety profile of pemetrexed (Alimta) treatment
Time frame: Jan 2010
pharmacokinetic analysis of half-life, maximum plasma concentration (Cpmax), clearance (CL), area under the curve (AUC), and apparent volume of distribution
Time frame: Jan 2010
evaluate the relationship between the expression of alpha folate receptor protein, TS and clinical response
Time frame: Jan 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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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.
Li Zhang, Master principal investigator
Cancer Center of Sun-Yat Sen University (CCSYSU)
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 (Alimta) in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen 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 13 inclusion and 12 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: finished, as of the sponsor's last update on 16 Feb 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: Jan 2010). 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 16 Feb 2012.