Clinical trial NCT00227669 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: docetaxel, gemcitabine hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
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