Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Pemetrexed in Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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)
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

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided by University Hospital Tuebingen

Additional 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Additional relevant MeSH terms:
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
 Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015