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Pemetrexed in Patients With Soft Tissue Sarcoma
This study has been completed.
Sponsor:
University Hospital Tuebingen
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00427466
First received: January 26, 2007
Last updated: February 13, 2009
Last verified: February 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Sarcoma | Drug: Pemetrexed | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Phase II Study With Pemetrexed in Patients With Pre-Treated Metastatic Soft Tissue Sarcomas |
Resource links provided by NLM:
Further study details as provided by University Hospital Tuebingen:
Primary Outcome Measures:
- Rate of response
Secondary Outcome Measures:
- Rate of patients who are progression free at 3 and 6 months
- Changes in median period of survival
- Progression free survival
- Toxicity
| Enrollment: | 54 |
| Study Start Date: | January 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427466
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427466
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00427466 History of Changes |
| Other Study ID Numbers: |
jth_006 |
| Study First Received: | January 26, 2007 |
| Last Updated: | February 13, 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 |
ClinicalTrials.gov processed this record on June 23, 2017