Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy
This study has been completed.
Eli Lilly and Company
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
First received: February 25, 2008
Last updated: February 14, 2012
Last verified: February 2012
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.
Drug: Pemetrexed (Alimta)
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open-Label Single-Arm Phase 2 Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Had Prior Platinum Based Chemotherapy
Primary Outcome Measures:
- response rate [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression-free survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
- safety profile of pemetrexed (Alimta) treatment [ Time Frame: Jan 2010 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- evaluate the relationship between the expression of alpha folate receptor protein, TS and clinical response [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Drug: Pemetrexed (Alimta)
500 mg/m2 in Cycle 1, every 3 weeks, with folic acid and vitamin B12 supplementation.
Other Name: Alimta
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT00630149
|Cancer Center of Sun-Yat Sen University (CCSYSU)
|GuangZhou, Guangdong, China, 510000 |
Sun Yat-sen University
Eli Lilly and Company
||Li Zhang, Master
||Cancer Center of Sun-Yat Sen University (CCSYSU)
No publications provided
||Li Zhang, Professor, Sun Yat-sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 25, 2008
||February 14, 2012
||China: Food and Drug Administration
Keywords provided by Sun Yat-sen University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists