Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: Gemcitabine
- description
- Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months
- interventionNames
- Drug: gemcitabine hydrochloride
- type
- EXPERIMENTAL
- label
- Arm II: Gemcitabine + Docetaxel
- description
- Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months
- interventionNames
- Drug: docetaxel
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Anti-tumoral activity (objective response rate)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDuffaud 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.