Status:
COMPLETED
Phase I/II Study of Pazopanib and Cyclophosphamide in Patients With Platinum-resistant Recurrent Ovarian Cancer
Lead Sponsor:
Priv.-Doz. Dr. med. Joachim Rom
Conditions:
Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients...
Detailed Description
This study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated ...
Eligibility Criteria
Inclusion
- Written informed consent
- Female subjects ≥18 years of age
- Histologically or cytologically confirmed diagnosis of: epithelial ovarian cancer which is platinum resistant or platinum refractory,cancer of the fallopian tube, peritoneal cancer
- Patients must have failed available standard chemotherapy regimen
- Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting
- Performance status ECOG 0 - 2
- Adequate contraception
- Adequate organ function
- Measurable disease according to RECIST criteria.
- Able to swallow and retain oral medication.
- Life expectancy of at least 12 weeks.
Exclusion
- Any second malignancy within the last 5 years, with the exception of basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, 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.
- Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
- Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- Prolongation of corrected QT interval (QTc) \>480 msecs.
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Symptomatic peripheral vascular disease
- Coronary artery by-pass graft surgery
- Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- Macroscopic hematuria
- Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug
- Evidence of active bleeding or bleeding diathesis
- Known endobronchial lesions or involvement of large pulmonary vessels by tumor
- Prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
- Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days or 5 half-lives
- Prior antiangiogenic therapy.
- Is unable or unwilling to discontinue predefined prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to Visit 1 and for the duration of the study
- Any ongoing toxicity from prior anti-cancer therapy that is \> Grade 1 and/or that is progressing in severity.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Pregnancy
- More than 3 different chemotherapy regimens in advanced tumor setting
- Uncontrolled hypertension
- History of ischemic event (stroke, myocardial infarction, unstable angina, TIA, symptomatic peripheral vascular disease)
- History or clinical evidence of thrombo-embolic event
- History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6 months
- Active bleeding
- Signs/Suspicion of intestinal obstruction
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01238770
Start Date
November 1 2010
End Date
October 1 2015
Last Update
February 10 2016
Active Locations (5)
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1
Marienkrankenhaus Hamburg
Hamburg, Germany, 22087
2
Universitäts-Frauenklinik
Heidelberg, Germany, 69120
3
Klinikum Konstanz Gynäkologie und Geburtshilfe
Konstanz, Germany, 78464
4
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde
Mainz, Germany, 55131