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

Unicancer

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00217607

CDR0000441642

EU-20517

FRE-FNCLCC-SARCOME-06/0409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Paclitaxel

Experimental group

Description:

Paclitaxel 80 mg/m² Day 1, Day 8 and Day 15. No treatment on Day 22. 1 cycle = 28 days. Treatment duration: 6 cycles (=6 months)

Treatment:

Drug: paclitaxel