Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
  PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant