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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

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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00227669
First received: September 26, 2005
Last updated: December 13, 2009
Last verified: December 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227669

Locations
France
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, France, 80054
Contact: Brigitte Pautard, MD    33-3-2266-8950      
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Patrick Soulie    33-2-4135-2700      
C.H.G. Beauvais Recruiting
Beauvais, France, 60021
Contact: J.L. Dutel, MD    33-344-112-309    jl.dutel@ch-beauvais.fr   
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nguyen Binh Bui, MD    33-556-333-333      
C.H.U. de Brest Recruiting
Brest, France, 29609
Contact: Jean-Pierre Malhaire, MD    33-298-223-333 ext. 233-95      
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      
Hopital Louis Pasteur Recruiting
Colmar, France, 68024
Contact: Faress Husseini, MD    33-389-12-4486    fares.husseini@ch-colmar.rss.fr   
Centre de Lutte Contre le Cancer Georges-Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Nicolas Isambert, MD    33-3-8073-7506      
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   
CHU Nord Recruiting
Marseille, France, 13915
Contact: Raha Shojai, MD    33-4-9196-4672    rahashojai@yahoo.com   
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   
CHR Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Bruno Buecher    33-2-4008-3151      
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   
CHR D'Orleans - Hopital de la Source Recruiting
Orleans, France, 45067
Contact: Remy Leloup, MD    38-51-45-15    remy.leloup@CHR-orleans.fr   
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Sophie Piperno-Neumann, MD    33-1-4432-4681      
Hopital Cochin Recruiting
Paris, France, 75674
Contact: Francois Goldwasser, MD, PhD    33-158-411-746    francois.goldwasser@cch.aphp.fr   
Hopital Saint-Louis Recruiting
Paris, France, 75475
Contact: Guihem Bousquet, MD    33-1-4249-9783      
Hopital Bichat - Claude Bernard Recruiting
Paris, France, 75018
Contact: Thomas Aparicio    33-1-4025-7200    thomas.aparicio@bch.ap-hop-paris.fr   
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Nadia Raban    33-549-444-538      
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: Patricia Pautier, MD    33-1-42-114-517    pautier@igr.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Florence Duffaud, MD CHU de la Timone
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00227669     History of Changes
Other Study ID Numbers: CDR0000443572, FRE-FNCLCC-SARCOME-07/0410, EU-20518
Study First Received: September 26, 2005
Last Updated: December 13, 2009
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

Additional relevant MeSH terms:
Leiomyosarcoma
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Docetaxel
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014