Pemetrexed in Patients With Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427466
• Other study ID #: jth_006
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2007
• Last updated: February 13, 2009
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• Pemetrexed

Locations

Country	Name	City	State
Germany	Medical Center II, University of Tuebingen	Tuebingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of response
Secondary	Rate of patients who are progression free at 3 and 6 months
Secondary	Changes in median period of survival
Secondary	Progression free survival
Secondary	Toxicity