Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma
Randomized Phase II Study Evaluating the Efficacy of Gemcitabine Versus the Gemcitabine/Docetaxel Combination as Second Line Treatment in Metastatic or Relapsed and Inoperable Uterine or Soft Tissue Leiomyosarcomas
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.
연구 개요
상세 설명
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 gemcitabine with vs without docetaxel as second-line therapy.
Secondary
- Compare the progression-free survival of patients treated with these regimens.
- Compare the response duration and overall survival of patients treated with these regimens.
- Compare the tolerability and dose intensity of these regimens in these patients.
- Determine biological markers with a predictive value for response to these regimens in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to location of leiomyosarcoma (uterine vs soft tissue). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine on days 1, 8, and 15. Treatment repeats every 4 weeks for 2-8 courses.
- Arm II: Patients receive gemcitabine on days 1 and 8 and docetaxel on day 8. Treatment repeats every 3 weeks for 2-8 courses.
PROJECTED ACCRUAL: A minimum of 80 patients (40 per stratum and treatment arm) will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Amiens, 프랑스, 80054
- Centre Hospitalier Universitaire D'Amiens
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Angers, 프랑스, 49036
- Centre Paul Papin
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Beauvais, 프랑스, 60021
- C.H.G. Beauvais
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Bordeaux, 프랑스, 33076
- Institut Bergonie
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Brest, 프랑스, 29609
- C.H.U. de Brest
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Caen, 프랑스, 14076
- Centre Regional Francois Baclesse
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Clermont-Ferrand, 프랑스, 63011
- Centre Jean Perrin
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Colmar, 프랑스, 68024
- Hôpital Louis Pasteur
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Dijon, 프랑스, 21079
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Lille, 프랑스, 59020
- Centre Oscar Lambret
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Lyon, 프랑스, 69437
- Hopital Edouard Herriot - Lyon
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Lyon, 프랑스, 69373
- Centre Léon Bérard
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Marseille, 프랑스, 13385
- CHU de la Timone
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Marseille, 프랑스, 13915
- CHU Nord
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Montpellier, 프랑스, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nantes, 프랑스, 44093
- CHR Hotel Dieu
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Nantes-Saint Herblain, 프랑스, 44805
- Centre Regional Rene Gauducheau
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Nice, 프랑스, 06189
- Centre Antoine Lacassagne
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Orleans, 프랑스, 45067
- CHR D'Orleans - Hopital de la Source
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Paris, 프랑스, 75018
- Hopital Bichat - Claude Bernard
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Paris, 프랑스, 75674
- Hôpital Cochin
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Paris, 프랑스, 75475
- Hôpital Saint-Louis
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Paris, 프랑스, 75248
- Institut Curie Hopital
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Poitiers, 프랑스, 86021
- CHU Poitiers
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Rennes, 프랑스, 35042
- Centre Eugene Marquis
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Rouen, 프랑스, 76038
- Centre Henri Becquerel
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Rouen, 프랑스, 76031
- Hôpital Charles Nicolle
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Saint Cloud, 프랑스, 92211
- Centre René Huguenin
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Saint Priest en Jarez, 프랑스, 42270
- Institut de Cancérologie de la Loire
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Toulouse, 프랑스, 31052
- Institut Claudius Regaud
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Tours, 프랑스, 37044
- Centre Hospitalier Universitaire Bretonneau de Tours
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Villejuif, 프랑스, F-94805
- Institut Gustave Roussy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Arm I: Gemcitabine
Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months |
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실험적: Arm II: Gemcitabine + Docetaxel
Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Anti-tumoral activity (objective response rate)
기간: 6 months
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6 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
전반적인 생존
기간: 3 년
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3 년
|
|
무진행 생존
기간: 6 개월
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6 개월
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응답 시간
기간: 3 년
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3 년
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|
Tolerability
기간: 3 years
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3 years
|
|
Dose intensity
기간: 3 years
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3 years
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Biological markers
기간: 3 years
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3 years
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Florence Duffaud, MD, CHU de la Timone
간행물 및 유용한 링크
일반 간행물
- Duffaud F, Bui BN, Penel N, et al.: A FNCLCC French Sarcoma Group--GETO multicenter randomized phase II study of gemcitabine (G) versus gemcitabine and docetaxel (G+D) in patients with metastatic or relapsed leiomyosarcoma (LMS). [Abstract] J Clin Oncol 26 (Suppl 15): A-10511, 2008.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000443572
- FRE-FNCLCC-SARCOME-07/0410
- EU-20518
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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