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

Sarcoma, Soft Tissue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00204568
• Other study ID #: jth_001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 7, 2013
• Start date: August 2004
• Est. completion date: October 2013

Study information

• Verified date: January 2013
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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).

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 117
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• Adriamycin
60 mg/m2, d1, W d22
• Trofosfamide
300 mg absolute d1-7, followed by 150 mg absolute continuously

Locations

Country	Name	City	State
Germany	University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University	Kiel

Sponsors (4)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Arbeitsgemeinschaft fur Internistische Onkologie, French Sarcoma Group, German Sarcoma Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival after 6 months	Progression-free survival after 6 months	after 6 months	Yes
Secondary	Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30	Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30		Yes