Status:
COMPLETED
Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
Lead Sponsor:
UNICANCER
Conditions:
Sarcoma
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
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. Givin...
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 g...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00227669
Start Date
October 1 2005
End Date
August 1 2012
Last Update
August 30 2016
Active Locations (32)
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1
Centre Hospitalier Universitaire d'Amiens
Amiens, France, 80054
2
Centre Paul Papin
Angers, France, 49036
3
C.H.G. Beauvais
Beauvais, France, 60021
4
Institut Bergonie
Bordeaux, France, 33076