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

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