Pemetrexed in Patients With Soft Tissue Sarcoma

February 13, 2009 updated by: University Hospital Tuebingen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of response

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

January 26, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jth_006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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