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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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Centre Paul Papin, Angers, France
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
Primary outcomes
-
Objective Response Rate
Time frame: 2 months
Secondary outcomes
-
Response rate
Time frame: 4 months
-
Response rate
Time frame: 6 months
-
Tolerability
Time frame: 6 months
-
Time to progression
Time frame: 5 years
-
Overall survival
Time frame: 5 years
-
Clinical criteria predicting response
Time frame: 2 months
-
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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