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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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
docetaxel
gemcitabine hydrochloride
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire d'Amiens
  • Centre Paul Papin
  • C.H.G. Beauvais
  • Institut Bergonie
  • C.H.U. de Brest
  • Centre Regional Francois Baclesse
  • Centre Jean Perrin
  • Hopital Louis Pasteur
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Hopital Edouard Herriot - Lyon
  • CHU de la Timone
  • CHU Nord
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Regional Rene Gauducheau
  • CHR Hotel Dieu
  • Centre Antoine Lacassagne
  • CHR D'Orleans - Hopital de la Source
  • Hopital Bichat - Claude Bernard
  • Institut Curie Hopital
  • Hopital Saint-Louis
  • Hopital Cochin
  • CHU Poitiers
  • Centre Eugene Marquis
  • Hopital Charles Nicolle
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Institut de Cancerologie de la Loire
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I: Gemcitabine

Arm II: Gemcitabine + Docetaxel

Arm Description

Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months

Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months

Outcomes

Primary Outcome Measures

Anti-tumoral activity (objective response rate)

Secondary Outcome Measures

Progression-free survival
Response duration
Tolerability
Dose intensity
Overall survival
Biological markers

Full Information

First Posted
September 26, 2005
Last Updated
August 29, 2016
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00227669
Brief Title
Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I: Gemcitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months
Arm Title
Arm II: Gemcitabine + Docetaxel
Arm Type
Experimental
Arm Description
Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Primary Outcome Measure Information:
Title
Anti-tumoral activity (objective response rate)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6 months
Title
Response duration
Time Frame
3 years
Title
Tolerability
Time Frame
3 years
Title
Dose intensity
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
Title
Biological markers
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Duffaud, MD
Organizational Affiliation
CHU de la Timone
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
C.H.U. de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared at an individual level.
Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

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