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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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