Pemetrexed in Patients With Soft Tissue Sarcoma

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Sarcoma	Drug: Pemetrexed	Phase 2

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 22

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas
Study Start Date :	January 2007
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	December 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Rate of response

Secondary Outcome Measures :

1. Rate of patients who are progression free at 3 and 6 months
2. Changes in median period of survival
3. Progression free survival
4. Toxicity

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Germany
Medical Center II, University of Tuebingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Arbeitsgemeinschaft fur Internistische Onkologie

German Sarcoma Group

Investigators

Principal Investigator:	Joerg T Hartmann, MD	Medical Center II, University of Tuebingen, Germany

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hartmann JT, Bauer S, Egerer G, Horger MS, Kopp HG, Grünwald 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.

ClinicalTrials.gov Identifier:	NCT00427466 History of Changes
Other Study ID Numbers:	jth_006
First Posted:	January 29, 2007
Last Update Posted:	February 16, 2009
Last Verified:	February 2009

Additional relevant MeSH terms:

Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pemetrexed	Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors