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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leiomyosarcoma

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

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

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Patricia Pautier, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy Institute

Authority:

France: Committee for the Protection of Personnes

Study ID:

SARCOME 11/1101

NCT ID:

NCT01442662

Start Date:

September 2011

Completion Date:

September 2017

Related Keywords:

  • Leiomyosarcoma
  • Metastatic or relapsed uterine or soft tissue leiomyosarcoma
  • Leiomyosarcoma

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