Open-Label Single-Arm Phase 2 Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Had Prior Platinum Based Chemotherapy
- 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
- Pregnancy or breast feeding.
- History of significant neurological or mental disorder, including seizures or
- 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