Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
Information provided by (Responsible Party):
J. T. Hartmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00204568
First received: September 13, 2005
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).


Condition Intervention Phase
Sarcoma, Soft Tissue
Drug: Adriamycin
Drug: Trofosfamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Progression-free survival after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
    Progression-free survival after 6 months


Secondary Outcome Measures:
  • Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30 [ Designated as safety issue: Yes ]
    Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30


Estimated Enrollment: 117
Study Start Date: August 2004
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Adriamycin mono
Drug: Adriamycin
60 mg/m2, d1, W d22
Experimental: 2
Trofosfamide
Drug: Trofosfamide
300 mg absolute d1-7, followed by 150 mg absolute continuously

Detailed Description:

Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
  • Grading II/III (Guillou et al. J Clin Oncol 1997)
  • At least 1 measurable tumor parameter according to RECIST criteria
  • Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
  • No previous radiation therapy of the only measurable lesion
  • No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months
  • Patients aged 60 years and beyond
  • Written patient informed consent
  • ECOG Status 0-2
  • Granulocytes >= 2 x 10**9/l and thrombocytes >= 100 x 10**/l
  • Serum creatinine, bilirubin < 1.5 times the upper limit of normal value, albumin > 25 g/l
  • No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease
  • Normal left-ventricular function by echocardiography or MUGA scan
  • No symptomatic CNS metastases
  • Willingness to receive regular follow-up examinations

Exclusion Criteria:

  • Histological grading of malignancy: G I
  • Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
  • Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
  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: NCT00204568

Locations
Germany
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
Investigators
Principal Investigator: Joerg T. Hartmann, MD University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
  More Information

No publications provided

Responsible Party: J. T. Hartmann, Prof. Dr. med. J. T. Hartmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00204568     History of Changes
Other Study ID Numbers: jth_001
Study First Received: September 13, 2005
Last Updated: January 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Trofosfamide
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014