Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or L… (NCT00217607) | Clinical Trial Compass
CompletedPhase 2
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
France30 participantsStarted 2005-02
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.