recurrent/advanced follicular, papillary or anaplastic thyroid cancer MedDRA version: 14.1 Level: LLT Classification code 10016935 Term: Follicular thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10002240 Term: Anaplastic thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classificat
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration num
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. No other forms of chemotherapy or investigational anticancer agents therapy for at least 4 weeks before enrollment in study. 3. Performance status of 0 to 2 on the ECOG scale (Protocol Appendix B). 4. Evidence of measurable disease according to the RECIST criteria, which means: Patients must have clinically and/or radiographically documented measurable disease. At least one site of disease must be unidimensionally measurable as follows: X-ray, physical exam > 20 mm Spiral CT scan > 10 mm Non-spiral CT scan > 20 mm All radiology studies must be performed within 28 days prior to registration (35 days if negative). 5. 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. 6. Adequate organ function including the following: • Adequate bone marrow reserve: platelets 100 x 109/L, hemoglobin 9 g/dl, absolute granulocyte count (AGC) >1.5 x 109/L. • Hepatic: bilirubin ?1.5 times upper limit of normal, aspartate transaminase (AST) and alanine transaminase (ALT) ?3.0 times normal (AST and ALT ?5.0 times normal is acceptable if due to liver metastases). • Renal: calculated creatinine clearance ?45 ml/min, using MDRD-formula (see http://nephron.com/cgi-bin/MDRDSIdefault.cgi) 7. 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). 8. 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. 9. 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). 10. For men and women of childbearing potential appropriate contraceptive precautions should be taken during the trial and for 3 months afterwards. 11. 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)). 12. No evidence of peripheral neuropathy greater than CTC Grade 1. 13. No prior taxane and/or pemetrexed (Alimta?) therapy. 14. Ability to discontinue administration of acetysalicylate (Aspirin®) and other nonsteroidal anti-inflammatory agents (NSAID) in case of higher daily dosages (e.g. > 1.3 g), the day of, for 2 days before, and 2 days after the dose of pemetrexed (Alimta?) (5 days prior for long-acting agents such as piroxicam).Exceptions for selective cyclooxygenase II-inhibitors in analgesic treatment may be discussed. 15. No clinically significant effusions (pleural or peritoneal), or albumin <2.5 g/dl at the time of study treatment application. The drainage of effusions
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Follicular and papillary thyroid cancer (DTC): efficacy measured by tumor response rate •Anaplastic thyroid cancer (ATC): efficacy measured by disease control rate after 2 cycles ;Secondary Objective: •efficacy variables including: duration of response, duration of stable disease (especially for ATC), time to progressive disease (TTP), survival time • toxicity ;Primary end point(s): Primary endpoint of the study is the measurement of the objective response rate. | — |
Countries
Germany
Outcome results
None listed