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

Leiomyosarcoma Clinical Trial

— LMS03  

Official title:

Phase II Multicenter Study to Determine the Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442662
• Other study ID #: SARCOME 11/1101
• Secondary ID: 2011-001308-36
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: May 28, 2019

Study information

• Verified date: January 2020
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 28, 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Main 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)

Related Conditions & MeSH terms

• Leiomyosarcoma

Intervention

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

Locations

Country	Name	City	State
France	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	CHU Timone	Marseille
France	Institut Paoli Calmettes	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	Vandoeuvre les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	To assess the 9-month Progression Free Survival in Patients With Metastatic or Relapsed Uterine or Soft Tissue Leiomyosarcomas and treated with Gemcitabine and Pazopanib	9 months
Secondary	disease control rate and overall response rate		12 weeks
Secondary	Safety of the combination Gemcitabine-Pazopanib	The severity of the adverse events and toxicity will be graded according to the NCI CTC-AE v4.0	during the entire trial
Secondary	metabolic response by using PET scan	First PET scan at baseline and the second one at 6 weeks after the first administration	6 weeks