Pemetrexed in Patients With Soft Tissue Sarcoma

University Hospital Tuebingen

Status and phase

Completed

Phase 2

Conditions

Sarcoma

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT00427466

jth_006

Details and patient eligibility

About

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

Full 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

Enrollment

54 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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