Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227669
• Other study ID #: CDR0000443572
• Secondary ID: FRE-FNCLCC-SARCO
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2005
• Last updated: August 29, 2016
• Start date: October 2005
• Est. completion date: August 2012

Study information

• Verified date: August 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyosarcoma
• Sarcoma

Intervention

Drug:
• docetaxel

• gemcitabine hydrochloride

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens
France	Centre Paul Papin	Angers
France	C.H.G. Beauvais	Beauvais
France	Institut Bergonie	Bordeaux
France	C.H.U. de Brest	Brest
France	Centre Regional Francois Baclesse	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	Hopital Louis Pasteur	Colmar
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Hopital Edouard Herriot - Lyon	Lyon
France	CHU de la Timone	Marseille
France	CHU Nord	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	CHR Hotel Dieu	Nantes
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Cochin	Paris
France	Hopital Saint-Louis	Paris
France	Institut Curie Hopital	Paris
France	CHU Poitiers	Poitiers
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Hopital Charles Nicolle	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

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 2

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-tumoral activity (objective response rate)		6 months	No
Secondary	Progression-free survival		6 months	No
Secondary	Response duration		3 years	No
Secondary	Tolerability		3 years	Yes
Secondary	Dose intensity		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Biological markers		3 years	No