NCT01238770

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 with recurrent, pretreated ovarian cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

3.9 years

First QC Date

November 10, 2010

Last Update Submit

February 8, 2016

Conditions

Epithelial Ovarian Cancer

Keywords

Ovarian cancer

Outcome Measures

Primary Outcomes (2)

  • Determination of the optimal doses for pazopanib (phase I)

    42 months

  • Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II)

    12 weeks after start of treatment

Secondary Outcomes (5)

  • Time to progression (TTP) according to RECIST criteria

    7 years

  • Overall survival

    7 years

  • Evaluation of CA125 tumour response

    7 years

  • Number of patients with Adverse Events

    7 years

  • Assessment of quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire

    7 years

Study Arms (1)

Cyclophosphamid + Pazopanib

EXPERIMENTAL

Cyclophosphamid + Pazopanib

Drug: Pazopanib

Interventions

PazopanibDRUG

Phase I Cyclophosphamid Pazopanib Dose level I 50 mg/day 400 mg/day Dose level II 50 mg/day 600 mg/day Dose level III 50 mg/day 800 mg/day Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally Phase II: Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally The dose for the phase II part of the trial will be based on the MTD of phase I.

Also known as: Cyclophosphamid
Cyclophosphamid + Pazopanib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Marienkrankenhaus Hamburg

Hamburg, 22087, Germany

Location

Universitäts-Frauenklinik

Heidelberg, 69120, Germany

Location

Klinikum Konstanz Gynäkologie und Geburtshilfe

Konstanz, 78464, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde

Mainz, 55131, Germany

Location

Universitätsfrauenklinik Tübingen Klinik für Gynäkologie und Geburtshilfe

Tübingen, 72076, Germany

Location

Related Publications (2)

  • Dinkic C, Eichbaum M, Schmidt M, Grischke EM, Gebauer G, Fricke HC, Lenz F, Wallwiener M, Marme F, Schneeweiss A, Sohn C, Rom J. Pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant, recurrent, pre-treated ovarian cancer - Results of the PACOVAR-trial. Gynecol Oncol. 2017 Aug;146(2):279-284. doi: 10.1016/j.ygyno.2017.05.013. Epub 2017 May 19.

    PMID: 28528917DERIVED

  • Eichbaum M, Mayer C, Eickhoff R, Bischofs E, Gebauer G, Fehm T, Lenz F, Fricke HC, Solomayer E, Fersis N, Schmidt M, Wallwiener M, Schneeweiss A, Sohn C. The PACOVAR-trial: a phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer. BMC Cancer. 2011 Oct 20;11:453. doi: 10.1186/1471-2407-11-453.

    PMID: 22014006DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialOvarian Neoplasms

Interventions

pazopanibCyclophosphamide

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Michael Eichbaum, PD Dr. med.

    Medizinische Fakultät Heidelberg Abteilung für Frauenheilkunde und Geburtshilfe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

DE(5)