Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 75 EORTC-62941

Objectives

I.  Compare the time to disease progression in patients with locally advanced 
and/or metastatic soft tissue sarcoma treated with docetaxel (TXT) vs. 
doxorubicin (DOX) as first-line chemotherapy.

II.  Evaluate the response rate, duration of response, survival, toxicity of 
treatment, and quality of life in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven soft tissue sarcoma that is locally advanced and/or
metastatic and considered incurable by surgery or radiotherapy, including:
  Malignant fibrous histiocytoma        Liposarcoma
  Synovial sarcoma                      Malignant paraganglioma
  Fibrosarcoma                          Leiomyosarcoma
  Angiosarcoma                          Malignant hemangiopericytoma
  Neurogenic sarcoma                    Mixed mesodermal tumors of the uterus
  Unclassified sarcoma                  Miscellaneous sarcoma

The following histologies are not eligible:
  Malignant mesothelioma                Chondrosarcoma
  Neuroblastoma                         Osteosarcoma
  Ewing's sarcoma                       Embryonal rhabdomyosarcoma

At least 1 bidimensionally measurable, previously unirradiated indicator
lesion that has progressed within 4 weeks prior to treatment required
  Lesion at least 2 cm in 1 diameter by CT or ultrasound
  Lung lesion surrounded by aerated lung at least 1 x 1 cm by x-ray
  Skin nodule or superficial lymph node at least 1 x 1 cm by physical exam

Not considered measurable:
  Bone metastasis
  Ascites
  Pleural or pericardial effusion
  Carcinomatous lymphangitis (skin and lung)
  Palpable, nonmeasurable abdominal mass
  Lesion evaluable by endoscopy alone
  Ulcerated lesion
  New lesion in previously irradiated field

No brain or leptomeningeal metastases

No pleural effusion of more than 1 liter unless evacuated with pleurocentesis
prior to entry

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No concurrent prednisone (or equivalent) unless:
     Dose 20 mg or less
     Treatment initiated more than 6 months prior to entry

Radiotherapy:
  At least 4 weeks since radiotherapy (8 weeks since extensive radiotherapy)

Surgery:
  Not specified

Other:
  More than 30 days since any investigational agent

Patient Characteristics:

Age:
  18-75

Performance status:
  WHO 0-2

Life expectancy:
  At least 12 weeks

Hematopoietic:
  ANC at least 2,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.25 x ULN
  SGOT no greater than 2 x ULN (3 x ULN with proven liver metastases)

Renal:
  Creatinine no greater than 1.6 mg/dl (140 micromoles/liter)

Cardiovascular:
  No prior MI
  No CHF
  No angina
  No uncontrolled hypertension
  No uncontrolled arrhythmia

Other:
  Accessible for treatment and follow-up at participating center
  No symptomatic peripheral neuropathy of NCI grade 2 or greater
  No history of significant neurologic or psychiatric disorders including:
     Psychotic disorders
     Dementia
     Seizures
  No contraindication to corticosteroids
  No unstable diabetes mellitus
  No evolutive ulcer
  No active uncontrolled infection
  No prior malignancy except:
     Adequately treated nonmelanomatous skin cancer
     Excised in situ cervical cancer
  No pregnant or nursing women
  Effective contraception required of fertile women

Blood/body fluid analyses and quality-of-life questionnaire within 3 days 
  prior to treatment
EKG within 7 days prior to treatment
Imaging/exams for tumor measurement and MUGA or echocardiogram within 14     
  days prior to treatment

Expected Enrollment

Up to 406 evaluable patients will be entered over approximately 28 months.

Outline

Randomized study.

Arm A:  Single-Agent Chemotherapy.  Docetaxel, TXT, NSC-628503.

Arm B:  Single-Agent Chemotherapy.  Doxorubicin, DOX, NSC-123127.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Jacob Verweij, MD, PhD, Protocol chair		Ph: 31-10-439-1338 Email: j.verweij@erasmusmc.nl