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Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas

Phase 2
18 Years
90 Years
Not Enrolling

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Trial Information

Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of response

Principal Investigator

Joerg T Hartmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Center II, University of Tuebingen, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2007

Completion Date:

December 2008

Related Keywords:

  • Sarcoma
  • Sarcoma