Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
UNICANCER
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00217607
First received: September 20, 2005
Last updated: December 13, 2009
Last verified: December 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective response rate at 2 months [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate at 4 and 6 months [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Clinical criteria predicting response [ Designated as safety issue: No ]
- Correlation of efficacy with the expression of genes involved in the angiogenesis regulation [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217607
Locations
| France | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49036 | |
| Contact: Philippe Maillart 33-2-4135-2700 | |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Recruiting |
| Besancon, France, 25030 | |
| Contact: Loic Chaigneau 33-81-668-240 | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Nguyen Binh Bui, MD 33-556-333-333 | |
| Centre Regional Francois Baclesse | Recruiting |
| Caen, France, 14076 | |
| Contact: Corinne Delcambre 33-2-3145-5000 | |
| Centre Jean Perrin | Recruiting |
| Clermont-Ferrand, France, 63011 | |
| Contact: Jacques-Olivier Bay, MD, PhD 33-73-278-080 | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Recruiting |
| Dijon, France, 21079 | |
| Contact: Pierre Fargeot, MD 33-38-073-7506 pfargeot@dijon.frclcc.fr | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Nicolas Penel, MD 33-3-20-295-920 | |
| Centre Leon Berard | Recruiting |
| Lyon, France, 69373 | |
| Contact: Isabelle Ray-Coquard, MD 33-4-78-78-26-45 | |
| Hopital Edouard Herriot - Lyon | Recruiting |
| Lyon, France, 69437 | |
| Contact: Jean-Yves Blay, MD, PhD 33-47-211-7398 jy.blay@chu-lyon.fr | |
| CHU de la Timone | Recruiting |
| Marseille, France, 13385 | |
| Contact: Florence Duffaud, MD 33-4-9138-5708 fduffaud@mail.ap-hm.fr | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Didier Cupissol, MD, PhD 33-4-6761-3100 dcupissol@valdorel.fnclcc.fr | |
| Centre Regional Rene Gauducheau | Recruiting |
| Nantes-Saint Herblain, France, 44805 | |
| Contact: Emmanuelle Bompas 33-2-40-479-959 | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Antoine Thyss, MD 33-04-9203-1538 antoine.thyss@cal.nice.fnclcc.fr | |
| Hopital Cochin | Recruiting |
| Paris, France, 75674 | |
| Contact: Francois Goldwasser, MD, PhD 33-158-411-746 francois.goldwasser@cch.aphp.fr | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Sophie Piperno-Neumann, MD 33-44-32-4000 | |
| Centre Eugene Marquis | Recruiting |
| Rennes, France, 35042 | |
| Contact: Pierre Kerbrat, MD, PhD 33-299-253-280 kerbrat@rennes.fnclcc.fr | |
| Centre Henri Becquerel | Recruiting |
| Rouen, France, 76038 | |
| Contact: Cecile Guillemet, MD 33-02-32-02-2237 cecile.guillemet@rouen.fnclcc.fr | |
| Hopital Charles Nicolle | Recruiting |
| Rouen, France, 76031 | |
| Contact: J.P. Vannier 33-2-3288-89-90 | |
| Centre Rene Huguenin | Recruiting |
| Saint Cloud, France, 92211 | |
| Contact: Michelle Tubiana-Hulin, MD 33-1-47-111-515 | |
| Institut de Cancerologie de la Loire | Recruiting |
| Saint Priest En Jarez, France, 42270 | |
| Contact: Olivier Collard, MD 33-477-91-7036 | |
| Institut Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau.christine@claudiusregaud.fr | |
| Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
| Tours, France, 37044 | |
| Contact: Lotfi Benboubker 33-02-4747-3712 | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, F-94805 | |
| Contact: Axel Le Cesne, MD 33-1-42-114-316 lecesne@igr.fr | |
Sponsors and Collaborators
UNICANCER
Investigators
| Study Chair: | Nicolas Penel, MD | Centre Oscar Lambret |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00217607 History of Changes |
| Other Study ID Numbers: | CDR0000441642, FRE-FNCLCC-SARCOME-06/0409, EU-20517 |
| Study First Received: | September 20, 2005 |
| Last Updated: | December 13, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult angiosarcoma recurrent adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Hemangiosarcoma Lymphangiosarcoma Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Lymphatic Vessel Tumors Paclitaxel |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013