Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine

NCT ID: NCT01442662

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2019-05-28

Brief Summary

The aim of this research is to study the activity of pazopanib in second line after anthracyclines in extra uterus and uterine LMS in association with gemcitabine.

Detailed Description

Primary Objectives:

To determine the PFS using combination of gemcitabine and pazopanib in patients with metastasis or relapse leiomyosarcoma (uterine or soft tissue)who have already received s first line anthracycline based therapy.

Secondary objectives:

To determine the disease control rate To determine the response rate To determine toxicities associated with combined gemcitabine and pazopanib To determine correlation between metabolic response and PFS

Design:

All eligible patients entering the study will receive daily oral pazopanib at 800mg, supplied as 200 mg aqueous film-coated tablets and 2 intravenous gemcitabine every three weeks (8 cycles max).

The treatment will continue until the development of unacceptable toxicity or evidence of disease progression or until patient's / investigator's decision of withdrawal.

Conditions

Leiomyosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pazopanib, gemcitabine

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

Group Type: EXPERIMENTAL

pazopanib + gemcitabine

Intervention Type: DRUG

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

Interventions

pazopanib + gemcitabine

pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of metastatic or relapsed of uterine or soft tissue leiomyosarcoma previously treated with one line of chemotherapy with at least an anthracycline. Patients who have received adjuvant therapy less than one year before relapse were considered to have received a first line therapy for metastatic disease)
• Delay between the end of previous treatment (chemotherapy, hormonotherapy, radiotherapy, immunotherapy, surgery or tumor embolisation) must be > 4 weeks
• At least one measurable lesion with RECIST criteria with progressive disease between the last 6 weeks between inclusion. One target at least must be in a non irradiated area
• performance status ECOG ≤ 2
• Age ≥ 18 years
• Subjects must provide written informed consent prior to performance of study-specific procedures, and must be willing to comply with treatment and follow up
• Adequate hematologic function
• Adequate coagulation function
• Adequate renal function
• Adequate liver function
• Patients must be affiliated to a Social Health Insurance
• Women of childbearing potential must be using a medically accepted method of contraception and must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the first study treatment.
• LVEF ≥ site limits

Exclusion Criteria

• Other uterine or soft tissue sarcomas
• Symptomatic or known brain metastasis
• Radiation therapy on the only evaluable lesion
• Anti coagulant treatment
• strong inhibitors or inducers of the isoenzyme CYP3A4 treatment
• Known sero-positivity (HIV, HbC, HbS)or uncontrolled infection
• other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• Clinically significant gastrointestinal abnormalities that may affect the absorption of the IP
• Corrected QT interval > 480 msec
• Other serious underlying pathology that would preclude study treatment
• Calcium and magnesium levels inferior to standard levels (measured within 14 days before the first pazopanib dose) and potassium levels inferior to standard levels (measured within 72 hours before the first pazopanib dose)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Pautier, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

Institut Bergonié

Bordeaux, , France

Centre François Baclesse

Caen, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre G.F Leclerc

Dijon, , France

Centre Oscar Lambret

Lille, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

CHU Timone

Marseille, , France

Centre Val d'Aurelle Paul Lamarque

Montpellier, , France

Institut de Cancérologie de l'Ouest/Centre René Gauducheau

Nantes Saint Herblain, , France

Centre Antoine Lacassagne

Nice, , France

Institut Curie - Hôpital Claudius Regaud

Paris, , France

Centre Henri Becquerel

Rouen, , France

Institut Curie - Hopital René Huguenin

Saint-Cloud, , France

Institut Claudius Regaud

Toulouse, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

Pautier P, Penel N, Ray-Coquard I, Italiano A, Bompas E, Delcambre C, Bay JO, Bertucci F, Delaye J, Chevreau C, Cupissol D, Bozec L, Eymard JC, Saada E, Isambert N, Guillemet C, Rios M, Piperno-Neumann S, Chenuc G, Duffaud F. A phase II of gemcitabine combined with pazopanib followed by pazopanib maintenance, as second-line treatment in patients with advanced leiomyosarcomas: A unicancer French Sarcoma Group study (LMS03 study). Eur J Cancer. 2020 Jan;125:31-37. doi: 10.1016/j.ejca.2019.10.028. Epub 2019 Dec 10.

Reference Type: DERIVED

PMID: 31835236 (View on PubMed)

Other Identifiers

2011-001308-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SARCOME 11/1101

Identifier Type: -

Identifier Source: org_study_id