Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00410462
Other study ID # EORTC-62061
Secondary ID EORTC-62061EUDRA
Status Active, not recruiting
Phase Phase 2
First received December 11, 2006
Last updated August 7, 2014
Start date October 2006

Study information

Verified date July 2010
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 118
Est. completion date
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma* of 1 of the following cellular types:

- Adipocytic (e.g., liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified)

- Fibroblastic (e.g., adult fibrosarcoma, myxofibrosarcoma, or sclerosing epithelioid fibrosarcoma)

- So-called fibrohistiocytic (e.g., pleomorphic malignant fibrous histiocytoma [MFH], giant cell MFH, or inflammatory MFH)

- Leiomyosarcoma

- Malignant glomus tumors

- Skeletal muscle (e.g., rhabdomyosarcoma, alveolar, or pleomorphic)

- Vascular (e.g., epithelioid hemangioendothelioma or angiosarcoma)

- Uncertain differentiation (e.g., synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor [PEComa], or intimal sarcoma)

- Malignant peripheral nerve sheath tumors

- Malignant solitary fibrous tumors

- Undifferentiated soft tissue sarcomas not otherwise specified

- Other types of sarcoma if approved by the study coordinator NOTE: *Includes malignant tumors of non-organ origin and skin and uterine leiomyosarcoma

- The following tumor types are excluded:

- 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
brostallicin

doxorubicin hydrochloride


Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (1)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 chemother — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Six-month progression-free survival, in terms of complete response, partial response, or no change No
Secondary Overall progression-free survival No
Secondary Objective tumor response No
Secondary Safety (CTCAE v 3.0) Yes
Secondary Duration of response No
Secondary Overall survival No
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2