Pemetrexed in Patients With Soft Tissue Sarcoma

NCT00427466 | Completed Phase 2

• 1 other identifier: jth_006
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• Rate of response

Secondary Outcomes (4)

• Rate of patients who are progression free at 3 and 6 months

• Changes in median period of survival

• Progression free survival

• Toxicity

Interventions

Pemetrexed DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Arbeitsgemeinschaft fur Internistische Onkologie: collaborator
• German Sarcoma Group: collaborator

Study Sites (1)

Medical Center II, University of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Hartmann JT, Bauer S, Egerer G, Horger MS, Kopp HG, Grunwald V, Mayer F. Pemetrexed in patients with refractory soft tissue sarcoma: a non-comparative multicenter phase II study of the German Sarcoma Group AIO-STS 005. Invest New Drugs. 2013 Feb;31(1):167-74. doi: 10.1007/s10637-012-9840-8. Epub 2012 Jul 5.

  PMID: 22763609 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Joerg T Hartmann, MD

  Medical Center II, University of Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

DE (1)