Phase 2 Trial of Pemetrexed (Alimta™) Combined With Paclitaxel in Patients With Recurrent/Advanced Follicular, Papillary or Anaplastic Thyroid Cancer
- Diagnosis of metastatic, histologically proven follicular/papillary or anaplastic
thyroid cancer without clinically meaningful surgical or radiotherapeutic options
and/or no amenability for radio-iodine therapy and evidence of progressive or
- No other forms of chemotherapy or investigational anticancer agents therapy for at
least 4 weeks before enrollment in study.
- Performance status of 0 to 2 on the ECOG scale.
- Evidence of measurable disease according to the RECIST criteria.
- Prior radiation therapy and surgery allowed if completed at least 2 weeks prior to
study enrollment, prior radioiodine treatment at least 3 months prior to study
enrollment and patients must have recovered from the acute toxic effects of the
treatment prior to study entry.
- Adequate organ function.
- No active infection (at the discretion of the investigator) or current central
nervous system (CNS) metastases or history of central nervous system metastases or
other serious concomitant systemic disorders incompatible with the study (at the
discretion of the investigator).
- No breast feeding nor pregnancy. For women of childbearing potential a negative serum
pregnancy-test has to be performed 7 days prior to inclusion into the study.
- No coexisting second malignancy or history of prior malignancy within the last 5
years. (Excluding basal or squamous cell carcinoma of the skin, superficial bladder
cancer and in situ carcinoma of the cervix with no evidence of recurrence).
- For men and women of childbearing potential appropriate contraceptive precautions
should be taken during the trial and for 3 months afterwards.
- No significant cardiovascular disease in the form of abnormal electrocardiogram (ECG)
coupled with clinical features of recent or recurrent symptomatic cardiac disease
(including myocardial infarction within the last year, uncontrolled angina,
arrhythmia or hypertension, severe congestive heart failure (NYHA >3)).
- No evidence of peripheral neuropathy greater than CTC Grade 1.
- No prior taxane and/or pemetrexed therapy.
- Ability to discontinue administration of acetysalicylate and other nonsteroidal
anti-inflammatory agents (NSAID) for 2 days before, the day of, and 2 days after the
dose of pemetrexed (5 days prior for long-acting agents such as piroxicam).
Exceptions for selective cyclooxygenase II-inhibitors in analgesic treatment may be
- No clinically significant effusions (pleural or peritoneal), or albumin <2.5 g/dl at
the time of study treatment application. The drainage of effusions prior to study
treatment application is possible.
- Inability of oral intake of folic acid or intramuscular vitamin B12 supplementation.
- At least 18 years of age and absence of any psychological, familial, sociological or
geographical condition potentially hampering compliance with the study protocol and
follow-up schedule; those conditions should be discussed with the patient before
registration in the trial
- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.
- Participation in another trial at the same time is not allowed.