patients with previously treated metastatic soft tissue sarcoma
Conditions
Interventions
Trade Name: Alimta
Product Name: Alimta
Product Code: Alimta
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: pemetrexed
Concentration unit: mg/m2 milligram(s)/square meter
Concentration
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed metastasized or locally inoperable soft tissue sarcoma - Progression or relapse after previous cytostatic treatment with adriamycin and/or an ifosfamide containing chemotherapeutic substance - Two-dimensionally measurable/evaluable tumor parameters - Previous radiotherapy is acceptable as long as the irradiated area does not include the only measurable lesion - Patient compliance and geographic proximity, which ensure the possibility of adequate Follow-up - Life expectancy of more than 3 months - ECOG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous or concurrent irradiation of the indicator lesion - Other concomitant tumor therapy - Severe impairment in hepatic function - Active Infection - Previous treatment with Pemetrexed - Second tumor within the past 5 years - Severely symptomatic cardiovascular and cerebrovascular disease - HIV, active Hepatitis B or C - Dementia, Cerebral stroke with cognitive deficits - Kidney function <= 79 ml/min (calculated according to MDRD) and inability to interrupt treatment with NSAIDs 2 days prior to and following administration of Pemetrexed - Inability or unwillingness to take folic acid, vitamin B12 or dexamethasone - Pleural or pericardial exudate, ascites without a drain (3rd Space) - Time Interval from the last course of chemotherapy < 4 weeks - Symptomatic CNS-Metastases - Gravidity or Lactation - Women of reproductive age without reliable contraception (neg. pregnancy test) - Participation in another clinical trial at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate of response;Secondary Objective: Determination of the rate of patients who are progression free at 3 and 6 months, changes in median period of survival and progression free survival, determination of toxicity;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed