Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
18 Years
70 Years
Both
Sarcoma
Trial Information
Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
OBJECTIVES:
Primary
- Determine the 2-month objective response rate in patients with locally advanced or
metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with
paclitaxel.
Secondary
- Determine the 4- and 6-month response rate in patients treated with this drug.
- Determine tolerability of this drug in these patients.
- Determine the time to disease progression and overall survival of patients treated with
this drug.
- Determine the clinical criteria predicting response in patients treated with this drug.
- Correlate the efficacy of this drug with the expression of genes involved in
angiogenesis regulation in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up
to 6 courses.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma
- Locally advanced or metastatic disease
- Unresectable disease
- Angiosarcomas in previously irradiated areas allowed provided disease is clearly
progressive
- Measurable disease
- No Kaposi's sarcoma
PATIENT CHARACTERISTICS:
Age
- 18 to 70
Performance status
- WHO 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 3 times upper limit of normal (ULN)
- SGOT and SGPT < 2.5 times ULN
- No severe liver failure
Renal
- Creatinine clearance > 60 mL/min
- No severe kidney failure
Cardiovascular
- LVEF ≥ 50%
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss ≥ 20% of body weight prior to illness
- Patient must be amenable to receiving care during the day
- No HIV positivity
- No clinical neuropathy
- No known allergy to study drug or to any of its components (e.g., Cremophor EL)
- No other progressive malignant tumor
- No chronic illness (somatic or psychiatric) that would preclude study compliance and
follow-up
- No psychological, geographical, or social reason that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 2 prior courses of chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- No other concurrent anticancer therapy
- No concurrent participation in another therapeutic investigational study
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response rate at 2 months
Safety Issue:
No
Principal Investigator
Nicolas Penel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Oscar Lambret
Authority:
Unspecified
Study ID:
CDR0000441642
NCT ID:
NCT00217607
Start Date:
February 2005
Completion Date:
Related Keywords:
- Sarcoma
- adult angiosarcoma
- recurrent adult soft tissue sarcoma
- stage III adult soft tissue sarcoma
- stage IV adult soft tissue sarcoma
- Hemangiosarcoma
- Lymphangiosarcoma
- Sarcoma
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