Efficacy of Gemcitabine With Pazopanib as Second Line Treatment in Patient With Metastatic or Relapsed Uterine (LMS03)

Unicancer

Status and phase

Completed

Phase 2

Conditions

Leiomyosarcoma

Treatments

Drug: pazopanib + gemcitabine

Study type

Interventional

Funder types

Other

Identifiers

NCT01442662

SARCOME 11/1101

2011-001308-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

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)