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

NCT ID: NCT00227669

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2012-08-31

Brief 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.

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.

Conditions

Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

gemcitabine hydrochloride

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Interventions

docetaxel

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Duffaud, MD

Role: STUDY_CHAIR

CHU de la Timone

Locations

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

Orléans, , France

Hopital Bichat - Claude Bernard

Paris, , France

Institut Curie Hopital

Paris, , France

Hopital Saint-Louis

Paris, , France

Hopital Cochin

Paris, , France

CHU Poitiers

Poitiers, , France

Centre Eugene Marquis

Rennes, , France

Hopital Charles Nicolle

Rouen, , France

Centre Henri Becquerel

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, , France

Countries

France

References

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.

Reference Type: RESULT

Other Identifiers

FRE-FNCLCC-SARCOME-07/0410

Identifier Type: -

Identifier Source: secondary_id

EU-20518

Identifier Type: -

Identifier Source: secondary_id

CDR0000443572

Identifier Type: -

Identifier Source: org_study_id