Pazopanib Vs. Pazopanib Plus Gemcitabine

Pazopanib Vs. Pazopanib Plus Gemcitabine in Patients with Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -

NCT02203760•North Eastern German Society of Gynaecological Oncology

View on ClinicalTrials.gov

Summary

This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours.

Detailed Description

Study design: This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours. Indication: Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas Randomization: Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy * Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or * Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A. Planned number of patients: 87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas Treatment schedules: Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A. Planned treatment duration per subject: Patients continue on study treatment until disease progression, death, unacceptable toxicity or withdrawal of consent for any reason.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Subjects must provide informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
•2. Histologically or cytological confirmed uterine leiomyosarcoma or uterine carcinosarcoma including any subtypes
•3. Patients with a contraindication for doxorubicin OR patients must have received prior chemotherapies
•4. For patients with prior anthracycline therapy normal cardiac function with LVEF at least 50% must be assessed by quantitative echocardiogram or MUGA scan
•5. Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks have elapsed since the last dose of therapy
•6. ECOG performance status 0-1
•7. At least 18 years old
•8. Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking - staging CT-scan after surgery)
•9. Able to swallow and retain oral medication
•10. Adequate organ system function as defined in Table 1
+24 more criteria

Exclusion Criteria

•1. Prior malignancy
•• Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
•2. Patient has received prior treatment with any anti-angiogenic agent including bevacizumab and tyrosine kinase inhibitors
•3. Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than LMS and CS
•4. History or clinical evidence of central nervous system (CNS) or leptomeningeal metastases, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
•5. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
•* Active peptic ulcer disease
•* Known intraluminal metastatic lesion/s with risk of bleeding
•* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
•* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
+30 more criteria

Locations (9)

Universitätsklinikum Bonn

Bonn, Bonn, Germany

Helios Klinikum Berlin-Buch, Klinik für Onkologie und Paliativmedizin

Berlin, Germany, Germany

Universitätsmedizin Greifswald Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

Greifswald, Greifswald, Germany

Helios Klinikum Bad Saarow, Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum

Bad Saarow, Germany

Universitätsmedizin Berlin Charité Campus Virchow-Klinikum

Berlin, Germany

Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden Klinik für Frauenheilkunde und Geburtshilfe

Dresden, Germany

Kliniken-Essen-Mitte Evang. Huyssens-Stiftung Klinik für Senologie / Brustzentrum

Essen, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsfrauenklinik Tübingen

Tübingen, Germany

Key Dates

Start Date

October 16, 2019

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

November 15, 2024

Enrollment

ACTUAL participants

Conditions

Leiomyosarcoma or Carcinosarcoma

Interventions

Pazopanib plus Gemcitabine

DRUG

Pazopanib

DRUG