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

NCT00227669 | Completed Phase 2

• 3 other identifiers: CDR0000443572FRE-FNCLCC-SARCOME-07/0410EU-20518
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 32

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. 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

Sarcoma

Keywords

uterine leiomyosarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; adult leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Anti-tumoral activity (objective response rate)

  6 months

Secondary Outcomes (6)

• Progression-free survival

  6 months

• Response duration

  3 years

• Tolerability

  3 years

• Dose intensity

  3 years

• Overall survival

  3 years

Study Arms (2)

Arm I: Gemcitabine

ACTIVE COMPARATOR

Gemcitabine at Day 1, Day 8 and Day 15. No treatment at Day 22. 1 cycle = 28 days. Treatment duration: 8 months

Drug: gemcitabine hydrochloride

Arm II: Gemcitabine + Docetaxel

EXPERIMENTAL

Gemcitabine at Day 1 and Day 8. No treatment at Day 15. Docetaxel at Day 8. 1 cycle = 21 days. Treatment duration: 6 months

Drug: docetaxel; Drug: gemcitabine hydrochloride

Interventions

docetaxel DRUG

Arm II: Gemcitabine + Docetaxel

gemcitabine hydrochloride DRUG

Arm I: Gemcitabine; Arm II: Gemcitabine + Docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (32)

Centre Hospitalier Universitaire d'Amiens

Amiens, 80054, France

Location

Centre Paul Papin

Angers, 49036, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

C.H.U. de Brest

Brest, 29609, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CHU Nord

Marseille, 13915, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Cochin

Paris, 75674, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Sarcoma; Leiomyosarcoma

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Florence Duffaud, MD

  CHU de la Timone

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: October 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2012
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (32)