Pemetrexed in Patients With Soft Tissue Sarcoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00427466 |
Recruitment Status :
Completed
First Posted : January 29, 2007
Last Update Posted : February 16, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma | Drug: Pemetrexed | Phase 2 |
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 |

- Rate of response
- Rate of patients who are progression free at 3 and 6 months
- Changes in median period of survival
- Progression free survival
- Toxicity

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427466
Germany | |
Medical Center II, University of Tuebingen | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Joerg T Hartmann, MD | Medical Center II, University of Tuebingen, Germany |
ClinicalTrials.gov Identifier: | NCT00427466 |
Other Study ID Numbers: |
jth_006 |
First Posted: | January 29, 2007 Key Record Dates |
Last Update Posted: | February 16, 2009 |
Last Verified: | February 2009 |
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 |