Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

NCT ID: NCT00410462

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.

Detailed Description

OBJECTIVES:

Primary

• Determine the activity and safety of brostallicin vs doxorubicin hydrochloride as first-line therapy in patients with relapsed, refractory, or metastatic soft tissue sarcoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
• Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.

Conditions

Ovarian Cancer; Sarcoma; Small Intestine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

brostallicin

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Embryonal rhabdomyosarcoma
• Chondrosarcoma
• Osteosarcoma
• Ewing tumors/primitive neuroectodermal tumor (PNET)
• Gastrointestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Inflammatory myofibroblastic sarcoma
• Neuroblastoma
• Malignant mesothelioma
• Mixed mesodermal tumors of the uterus
• Relapsed, refractory, and/or metastatic disease incurable by surgery or radiotherapy
• Measurable disease
• Must have formalin fixed paraffin-embedded tumor blocks and representative hematoxylin/eosin slides available for histological central review
• No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS:

• At least 60 years of age OR ≥ 18 years of age if patient is not suitable for intensive combination chemotherapy treatments
• WHO performance status 0-1
• Absolute neutrophil count > 2,000/mm³
• Platelet count > 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine clearance ≥ 60 mL/min
• No serious cardiac illness within the past 6 months, including, but not limited to the following:

• History of documented congestive heart failure
• High-risk uncontrolled arrhythmias
• Angina pectoris requiring antianginal medication
• Clinically significant valvular heart disease
• Evidence of transmural infarction on ECG
• Poorly-controlled hypertension (e.g., systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 100 mm Hg)
• Normal 12-lead ECG
• LVEF normal by MUGA or echocardiogram
• No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
• No other serious and/or unstable medical condition, illness, or lab abnormality that would preclude study participation
• No psychiatric illness or familial, social, or geographical condition that would preclude study compliance
• No active uncontrolled infection
• No known AIDS positivity
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy regimen for advanced or metastatic disease (neoadjuvant and adjuvant therapy allowed)
• No concurrent sargramostim (GM-CSF) except in cases of febrile neutropenia
• No other concurrent anticancer therapy or investigational agents, including any of the following:

• Chemotherapy
• Biological response modifiers
• Hormone therapy
• Immunotherapy
• No other concurrent clinical treatment trial participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Gelderblom, MD, PhD

Role: STUDY_CHAIR

Leiden University Medical Center

Locations

Leiden University Medical Center

Leiden, , Netherlands

Countries

Netherlands

References

Gelderblom H, Blay JY, Seddon BM, Leahy M, Ray-Coquard I, Sleijfer S, Kerst JM, Rutkowski P, Bauer S, Ouali M, Marreaud S, van der Straaten RJ, Guchelaar HJ, Weitman SD, Hogendoorn PC, Hohenberger P. Brostallicin versus doxorubicin as first-line chemotherapy in patients with advanced or metastatic soft tissue sarcoma: an European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group randomised phase II and pharmacogenetic study. Eur J Cancer. 2014 Jan;50(2):388-96. doi: 10.1016/j.ejca.2013.10.002. Epub 2013 Nov 8.

Reference Type: RESULT

PMID: 24215845 (View on PubMed)

Other Identifiers

EORTC-62061

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-001861-40

Identifier Type: -

Identifier Source: secondary_id

NERVIANO-BRTA-0100-015

Identifier Type: -

Identifier Source: secondary_id

EORTC-62061

Identifier Type: -

Identifier Source: org_study_id