Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00227669 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with docetaxel is more effective than giving gemcitabine alone as second-line therapy in treating uterine or soft tissue leiomyosarcoma.
PURPOSE: This randomized phase II trial is studying gemcitabine and docetaxel to see how well they work compared to gemcitabine alone as second-line therapy in treating patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas |
Estimated Enrollment: | 80 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to location of leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the following criteria:
Prior treatment with a first-line anthracycline-based chemotherapy regimen required
At least 1 measurable lesion, defined as the following:
No other uterine sarcomas, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
C.H.G. Beauvais | Recruiting |
Beauvais, France, 60021 | |
Contact: J.L. Dutel, MD 33-344-112-309 jl.dutel@ch-beauvais.fr | |
C.H.U. de Brest | Recruiting |
Brest, France, 29609 | |
Contact: Jean-Pierre Malhaire, MD 33-298-223-333 ext. 233-95 | |
Centre Antoine Lacassagne | Recruiting |
Nice, France, 06189 | |
Contact: Antoine Thyss, MD 33-04-9203-1538 antoine.thyss@cal.nice.fnclcc.fr | |
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Recruiting |
Dijon, France, 21079 | |
Contact: Nicolas Isambert, MD 33-3-8073-7506 | |
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 | |
Centre Hospitalier Universitaire Bretonneau de Tours | Recruiting |
Tours, France, 37044 | |
Contact: Lotfi Benboubker 33-02-4747-3712 | |
Centre Hospitalier Universitaire d'Amiens | Recruiting |
Amiens, France, 80054 | |
Contact: Brigitte Pautard, MD 33-3-2266-8950 | |
Centre Jean Perrin | Recruiting |
Clermont-Ferrand, France, 63011 | |
Contact: Jacques-Olivier Bay, MD, PhD 33-73-278-080 | |
Centre Leon Berard | Recruiting |
Lyon, France, 69373 | |
Contact: Isabelle Ray-Coquard, MD 33-4-78-78-26-45 | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Nicolas Penel, MD 33-3-20-295-920 | |
Centre Paul Papin | Recruiting |
Angers, France, 49036 | |
Contact: Patrick Soulie 33-2-4135-2700 | |
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 Francois Baclesse | Recruiting |
Caen, France, 14076 | |
Contact: Corinne Delcambre 33-2-3145-5000 | |
Centre Regional Rene Gauducheau | Recruiting |
Nantes-Saint Herblain, France, 44805 | |
Contact: Emmanuelle Bompas 33-2-40-479-959 | |
Centre Rene Huguenin | Recruiting |
Saint Cloud, France, 92211 | |
Contact: Michelle Tubiana-Hulin, MD 33-1-47-111-515 | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, F-94805 | |
Contact: Patricia Pautier, MD 33-1-42-114-517 pautier@igr.fr | |
CHR Hotel Dieu | Recruiting |
Nantes, France, 44093 | |
Contact: Bruno Buecher 33-2-4008-3151 | |
CHU de la Timone | Recruiting |
Marseille, France, 13385 | |
Contact: Florence Duffaud, MD 33-4-9138-5708 fduffaud@mail.ap-hm.fr | |
CHU Nord | Recruiting |
Marseille, France, 13915 | |
Contact: Raha Shojai, MD 33-4-9196-4672 rahashojai@yahoo.com | |
CHU Poitiers | Recruiting |
Poitiers, France, 86021 | |
Contact: Nadia Raban 33-549-444-538 | |
Hopital Bichat - Claude Bernard | Recruiting |
Paris, France, 75018 | |
Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr | |
Hopital Charles Nicolle | Recruiting |
Rouen, France, 76031 | |
Contact: J.P. Vannier 33-2-3288-89-90 | |
Hopital Cochin | Recruiting |
Paris, France, 75674 | |
Contact: Francois Goldwasser, MD, PhD 33-158-411-746 francois.goldwasser@cch.aphp.fr | |
Hopital Edouard Herriot - Lyon | Recruiting |
Lyon, France, 69437 | |
Contact: Jean-Yves Blay, MD, PhD 33-47-211-7398 jy.blay@chu-lyon.fr | |
Hopital Louis Pasteur | Recruiting |
Colmar, France, 68024 | |
Contact: Faress Husseini, MD 33-389-12-4486 fares.husseini@ch-colmar.rss.fr | |
Hopital Saint-Louis | Recruiting |
Paris, France, 75475 | |
Contact: Guihem Bousquet, MD 33-1-4249-9783 | |
Institut Bergonie | Recruiting |
Bordeaux, France, 33076 | |
Contact: Nguyen Binh Bui, MD 33-556-333-333 | |
Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Contact: Christine Chevreau-Dalbianco, MD 33-56-142-4114 chevreau@icr.fnclcc.fr | |
Institut Curie Hopital | Recruiting |
Paris, France, 75248 | |
Contact: Sophie Piperno-Neumann, MD 33-1-4432-4681 | |
Institut de Cancerologie de la Loire | Recruiting |
Saint Priest en Jarez, France, 42270 | |
Contact: Olivier Collard, MD 33-477-91-7036 | |
CHR D'Orleans - Hopital de la Source | Recruiting |
Orleans, France, 45067 | |
Contact: Remy Leloup, MD 38-51-45-15 remy.leloup@CHR-orleans.fr |
Study Chair: | Florence Duffaud, MD | CHU de la Timone |
Study ID Numbers: | CDR0000443572, FRE-FNCLCC-SARCOME-07/0410, EU-20518 |
Study First Received: | September 26, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00227669 |
Health Authority: | Unspecified |
uterine leiomyosarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
stage III uterine sarcoma stage IV uterine sarcoma recurrent uterine sarcoma adult leiomyosarcoma |
Docetaxel Neoplasms, Connective and Soft Tissue Leiomyosarcoma Malignant mesenchymal tumor Sarcoma |
Uterine sarcoma Gemcitabine Soft tissue sarcomas Recurrence |
Antimetabolites Neoplasms, Muscle Tissue Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |