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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00227669
First received: September 26, 2005
Last updated: August 29, 2016
Last verified: August 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 UNICANCER:

Primary Outcome Measures:
  • Anti-tumoral activity (objective response rate) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Dose intensity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Biological markers [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: October 2005
Study Completion Date: August 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I: Gemcitabine

Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22.

1 cycle = 28 days.

Treatment duration: 8 months

Drug: gemcitabine hydrochloride
Experimental: Arm II: Gemcitabine + Docetaxel

Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8.

1 cycle = 21 days.

Treatment duration: 6 months

Drug: docetaxel Drug: gemcitabine hydrochloride

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 to 120 Years   (Adult, Senior)
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
Amiens, France, 80054
Centre Paul Papin
Angers, France, 49036
C.H.G. Beauvais
Beauvais, France, 60021
Institut Bergonie
Bordeaux, France, 33076
C.H.U. de Brest
Brest, France, 29609
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Hopital Louis Pasteur
Colmar, France, 68024
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot - Lyon
Lyon, France, 69437
CHU de la Timone
Marseille, France, 13385
CHU Nord
Marseille, France, 13915
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
CHR Hotel Dieu
Nantes, France, 44093
Centre Antoine Lacassagne
Nice, France, 06189
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Hopital Bichat - Claude Bernard
Paris, France, 75018
Institut Curie Hopital
Paris, France, 75248
Hopital Saint-Louis
Paris, France, 75475
Hopital Cochin
Paris, France, 75674
CHU Poitiers
Poitiers, France, 86021
Centre Eugene Marquis
Rennes, France, 35042
Hopital Charles Nicolle
Rouen, France, 76031
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92211
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, F-94805
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.

Responsible Party: UNICANCER
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: August 29, 2016
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared at an individual level.

Keywords provided by UNICANCER:
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:
Sarcoma
Leiomyosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on December 09, 2016