Studien für das Tumorboard:
Bonn: Urologische Tumoren

Diagnosen

Karzinosarkom, Ovarialkarzinome (Eierstockkrebs), Peritonealkarcinose

Einschlusskriterien

- Die Patienten müssen vor der Durchführung studienspezifischer Bewertungen eine schriftliche Einwilligung nach Auflärung erteilen und bereit sein, die empfohlenen Behandlungs- und Folgebwertungen einzuhalten
- Fähigkeit, Fragebögen selbstständig auszufüllen
- Frauen im Alter von ≥ 18 Jahren
- Histologisch gesicherte Diagnose von epithelialem Eierstockkrebs oder Karzinomsarkom (EOC), primärem Peritonealkarzinom (PPC) oder Eileiterkrebs (FTC)
- Die Patienten müssen eine rezidivierende Krebserkrankung haben (CA 125, radiologische oder klinische Anzeichen eines Wiederauftretens oder Fortschreitens)
- Patienten, die für die Monochemotherapie mit Paclitaxel, PLD, Topotecan oder Treosulfan und unter optionaler Verwendung von Bevacizumab nach Entscheidung des behandelnden Arztes und nach Genehmigung empfohlen werden und die innerhalb von 2 Wochen nach Registrierung in dieser Studie mit der Therapie beginnen sollten
- Mindestens 1 vorherige Behandlungsschema für Eierstockkrebs (d.h. ab der zweiten Linie ist eine Behandlung zulässig)
- Eastern Cooperative Oncology Group (ECOG) Leistungsstatus von 0-3 %
- Eine Lebenserwartung von mindestens 12 Wochen

Sonstiges

Kontaktpersonen

boris.horn@uk-koeln.de

Ausschlusskriterien

- Patienten, die für eine kombinierte Chemotherapie oder eine Erhaltungsbehandlung nach einer vorherhigen Chemotherapie empfohlen werden oder nur für die Strahlentherapie vorgesehen sind.
- Chemotherapie oder Strahlentherapie oder Tumorembolisation innerhalb von 2 Wochen vor der Registrierung und Studienbewertung.
- Biologische Therapie, Immuntherapie, Hormontherapie oder Behandlung mit einem Prüfpräparat innerhalb von 21 Tagen.
- Jede instabile oder schwerwiegende Begleiterscheinung (z.B. aktive Infektion, die eine systematische Therapie erfordert).
- Rechtsunfähigkeit oder eingeschränkte Rechtsfähigkeit
- Medizinische oder psychologische Bedingungen, die es dem Probanden nicht ermöglichen würden, die Studienbewertungen abzuschließen oder die Einwilligung nach Aufklärung zu unterzeichnen.

Diagnosen

Karzinosarkom, Leiomyosarkom

Einschlusskriterien

Sonstiges

Kontaktpersonen

Ausschlusskriterien

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 nonmelanomatous

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

• Grade 3/4 diarrhea

6. Corrected QT interval (QTc) > 450 msecs using Barzett’s formula

7. History of any one or more of the following cardiovascular conditions within the past 6

months:

• Cardiac angioplasty or stenting

• Myocardial infarction

• Unstable angina

• Coronary artery bypass graft surgery

• Symptomatic peripheral vascular disease

• Class III or IV congestive heart failure, as defined by the New York Heart

Association (NYHA)

• Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140

mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg].

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior

to study entry. BP must be re-assessed on two occasions that are separated by a

minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP /

DBP values from each BP assessment must be <140/90 mmHg in order for a

subject to be eligible for the study (refer to study protocol for details on BP control

and re-assessment prior to study enrollment)

8. History of cerebrovascular accident including transient ischemic attack (TIA),

pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6

months.

• Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating

agents for at least 6 weeks are eligible

9. Major surgery or trauma within 28 days prior to study enrolment or any non- healing

wound, fracture or ulcer (procedures such as catheter placement not considered to

be major)

10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs

chemically related to Pazopanib or Gemcitabine

11. Evidence of active bleeding or bleeding diathesis

12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels

13. Hemoptysis in excess of 2.5 mL (or one half teaspoon) within 8 weeks prior to the first

dose of study drug

14. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that

could interfere with subject’s safety, provision of informed consent, or compliance to

study procedures

15. Unable or unwilling to discontinue use of prohibited medications listed in the study

protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to

the first dose of study drug and for the duration of the study

16. Treatment with any of the following anti-cancer therapies

- Radiation therapy, surgery or tumour embolization within 14 days prior to the first

dose of study drug

- Chemotherapy, immunotherapy, biologic therapy, investigational therapy or

hormonal therapy within 14 days or five half-lives of a drug (whichever is longer)

prior to the first dose of study drug

17. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is

progressing in severity, except alopecia

18. Pregnancy (for women of childbearing potential to be confirmed by negative serum

pregnancy test) or lactation period

Women of childbearing potential:

missing contraception (Pearl-Index <1, e.g. hormonal contraception including the

combined oral contraceptive pill, the transdermal patch, and the contraceptive

vaginal ring, intrauterine devices or sterilization) for 14 days before exposure to

investigational product, during study treatment and for at least 21 days after the last

dose of investigational product.

19. Medical or psychological conditions that would not permit the subject to complete the

study or sign informed consent

20. Legal incapacity or limited legal capacity

21. Participation in another clinical study with experimental therapy within 30 days prior to study enrolment