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Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Sarcoma, Small Intestine Cancer

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Trial Information

Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma



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

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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Six-month progression-free survival, in terms of complete response, partial response, or no change

Safety Issue:


Principal Investigator

Hans Gelderblom, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Leiden University Medical Center


United States: Federal Government

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • adult liposarcoma
  • adult fibrosarcoma
  • adult malignant fibrous histiocytoma
  • adult leiomyosarcoma
  • adult rhabdomyosarcoma
  • adult alveolar soft-part sarcoma
  • adult malignant mesenchymoma
  • adult angiosarcoma
  • adult epithelioid sarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • recurrent uterine sarcoma
  • stage IV uterine sarcoma
  • ovarian sarcoma
  • small intestine leiomyosarcoma
  • recurrent small intestine cancer
  • Ovarian Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms
  • Sarcoma