Sarcoma
Conditions
Brief summary
The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess the toxicity profile
Detailed description
One therapy cycle takes a total of 3 weeks. On day 1, Pemetrexed is intravenously administered. The dosage is 500 mg/m2 over a period of 10 minutes. A repetition of this procedure is performed on day 22
Interventions
DRUGPemetrexed
Sponsors
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 (according to WHO-criteria) * 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 * Patient ability to consent
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 (excepting basal cell carcinoma, adequately treated carcinoma in situ of the uterine cervix, of the bladder urothelium or colon polyps including pTis and pTin) * 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): Inability to interrupt treatment with NSAIDs/ASS/Cox-2 Inhibitors 2 days prior to and following administration of Pemetrexed. If a patient is taking an NSAID or salicylate with a long half-life it should not be taken five days prior to, on the day of or two days after application of Pemetrexed. Low dose acetyl salicylic acid administration is permitted (e.g. 100 mg/die.) There are no restrictions with kidney function greater than 80 ml/min. * 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 if not the following applies: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment * Positive serum or urine pregnancy test * Participation in another trial at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of response | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients who are progression free at 3 and 6 months | — |
| Changes in median period of survival | — |
| Progression free survival | — |
| Toxicity | — |
Countries
Germany
Outcome results
None listed