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Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2006
Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227669
  Purpose

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

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Docetaxel Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Anti-tumoral activity (objective response rate) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Dose intensity [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Biological markers [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

Primary

  • Compare the anti-tumor activity, in terms of objective response rate, in patients with metastatic or relapsed, unresectable uterine or soft tissue leiomyosarcoma treated with gemcitabine with vs without docetaxel as second-line therapy.

Secondary

  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the response duration and overall survival of patients treated with these regimens.
  • Compare the tolerability and dose intensity of these regimens in these patients.
  • Determine biological markers with a predictive value for response to these regimens in these patients.

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.

  • Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4 weeks for 2-8 courses.
  • Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment repeats every 3 weeks for 2-8 courses.

PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine or soft tissue leiomyosarcoma, meeting ≥ 1 of the following criteria:

    • Metastatic disease
    • Relapsed and unresectable disease
  • Prior treatment with a first-line anthracycline-based chemotherapy regimen required

    • Relapsed disease > 1 year after adjuvant chemotherapy is considered untreated disease
    • If relapsed disease occurs < 1 year after adjuvant therapy, then adjuvant therapy is considered a first-line treatment
  • At least 1 measurable lesion, defined as the following:

    • At least 1 target lesion must be located in a non-irradiated area
    • Obvious disease progression within the past 6 weeks
  • No other uterine sarcomas, including any of the following:

    • Carcinosarcoma
    • Endometrial stroma sarcoma
    • Other soft tissue sarcoma
  • No symptomatic or known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No specific hepatic contraindication to study treatment
  • Hepatitis B core and hepatitis B surface antigen negative

Renal

  • Creatinine < 1.5 times ULN
  • No specific renal contraindication to study treatment

Cardiovascular

  • No specific cardiac contraindication to study treatment

Immunologic

  • HIV negative
  • No specific allergic contraindication to study treatment
  • No active infection

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other serious underlying pathology that would preclude study treatment
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No neurotoxicity > grade 2
  • No psychological, sociological, or geographical condition that would preclude study compliance or follow-up schedule
  • No prior or concurrent psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No prior allogeneic graft or autologous graft

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No prior gemcitabine and/or taxane (i.e., docetaxel or paclitaxel)

Endocrine therapy

  • More than 4 weeks since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to the only evaluable lesion

Surgery

  • Not specified

Other

  • No concurrent participation in another clinical trial using an experimental agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227669

Locations
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    
Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators
Study Chair: Florence Duffaud, MD CHU de la Timone
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Docetaxel
Neoplasms, Connective and Soft Tissue
Leiomyosarcoma
Malignant mesenchymal tumor
Sarcoma
Uterine sarcoma
Gemcitabine
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009