Multicenter phase II study with pemetrexed in patients with pre-treated metastatic soft tissue sarcomas

Conditions: patients with previously treated metastatic soft tissue sarcoma

Registration Number: EUCTR2006-003816-23-DE

Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 <= 2
- Age at least 18 years
- Adequate bone marrow function at the initiation of therapy
- Adequate kidney function
- Patient consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):

Secondary Outcome Measures