Clinical trial · Interventional
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel
- 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)
- interventionNames
- Drug: paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 2 months
Secondary outcomes (7)
- measure
- Response rate
- timeFrame
- 4 months
- measure
- Response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTPenel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22. PMID 18809609