SarcomaPhase 2NCT00427466
Pemetrexed in Patients With Soft Tissue Sarcoma
A Phase 2 study testing Pemetrexed in people with Sarcoma, run by University Hospital Tuebingen at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Pemetrexed
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas
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
Read the 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
- Conditions
- Sarcoma
- Being tested
- Pemetrexed
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group
- Investigators
- Joerg T Hartmann, MD, Principal investigator, Medical Center II, University of Tuebingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427466
- Sponsor's protocol ID
- jth_006
- Status last verified
- Feb 2009
- First submitted
- 26 Jan 2007
- Last updated
- 16 Feb 2009
- Results posted
- No
Publications
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.
PubMed 22763609
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT00427466
- Acronym / sponsor ID
- jth_006
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (18 listed)
- Previous or concurrent irradiation of the indicator lesion
- Other concomitant tumor therapy
- Severe impairment in hepatic function
- Active Infection
- Previous treatment with Pemetrexed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemetrexed | Drug | – |
Primary outcome
Rate of response
4 secondary outcomes
Rate of patients who are progression free at 3 and 6 months
Changes in median period of survival
Progression free survival
Toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
- Derived from this study: PubMed 22763609Hartmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg T Hartmann, MD principal investigator
Medical Center II, University of Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed in people with Sarcoma, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2009.