Status:
COMPLETED
Pemetrexed in Patients With Soft Tissue Sarcoma
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Conditions:
Sarcoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 chemothera...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00427466
Start Date
January 1 2007
End Date
December 1 2008
Last Update
February 16 2009
Active Locations (1)
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1
Medical Center II, University of Tuebingen
Tübingen, Germany, 72076