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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Docetaxel; Gemcitabine

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