Trial | NCT00204568  Report issue

Title

Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    117
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).
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)
Study Started
Aug 31
2004
Primary Completion
Oct 31
2013
Anticipated
Study Completion
Oct 31
2013
Anticipated
Last Update
Jan 08
2013
Estimate

Drug Adriamycin

60 mg/m2, d1, W d22

Drug Trofosfamide

300 mg absolute d1-7, followed by 150 mg absolute continuously

1 Active Comparator

Adriamycin mono

2 Experimental

Trofosfamide

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
No Results Posted