Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
Sarcoma
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
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
Active Comparator
Experimental
Arm I: Gemcitabine
Arm II: Gemcitabine + Docetaxel
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