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OpenTrials
Completed

NCT Number: NCT00217607

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Paul Papin, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

Primary outcomes

  1. Objective Response Rate

    Time frame: 2 months

Secondary outcomes

  1. Response rate

    Time frame: 4 months

  2. Response rate

    Time frame: 6 months

  3. Tolerability

    Time frame: 6 months

  4. Time to progression

    Time frame: 5 years

  5. Overall survival

    Time frame: 5 years

  6. Clinical criteria predicting response

    Time frame: 2 months

  7. Correlation of efficacy with the expression of genes involved in the angiogenesis regulation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2012
First posted
Sep 22, 2005
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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