- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00630149
Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy
February 14, 2012 updated by: Li Zhang, Sun Yat-sen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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GuangZhou, Guangdong, China, 510000
- Cancer Center of Sun-Yat Sen University (CCSYSU)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: Jan 2010
|
Jan 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: Jan 2010
|
Jan 2010
|
overall survival
Time Frame: Jan 2010
|
Jan 2010
|
safety profile of pemetrexed (Alimta) treatment
Time Frame: Jan 2010
|
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
|
Jan 2010
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evaluate the relationship between the expression of alpha folate receptor protein, TS and clinical response
Time Frame: Jan 2010
|
Jan 2010
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Li Zhang, Master, Cancer Center of Sun-Yat Sen University (CCSYSU)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 25, 2008
First Submitted That Met QC Criteria
February 25, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Estimate)
February 16, 2012
Last Update Submitted That Met QC Criteria
February 14, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- H3E-GH-0034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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