NCT01747239

Brief Summary

Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed. Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has effect in patients refractory to taxotere. Consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

December 6, 2012

Last Update Submit

December 3, 2014

Conditions

Ovarian Cancer

Keywords

Ovarian cancerPlatinum refractory

Outcome Measures

Primary Outcomes (1)

  • Rate of response to cabazitaxel

    Response must be confirmed by a second CT scan 4-6 weeks after first response by CT scan

    Every 9 weeks up to two years

Secondary Outcomes (2)

  • Progression free survival

    Every three months until progression or death, up to three years

  • Overall survival

    Every 3 months up to three years

Study Arms (1)

Cabazitaxel

EXPERIMENTAL

25 mg/m2 IV every three weeks

Drug: Cabazitaxel

Interventions

CabazitaxelDRUG

25 mg/m2 IV every three weeks

Cabazitaxel

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or evaluable by Gynecologic Cancer Interest Group (GCIG) cancer antigen 125 (CA-125) criteria.
  • Age ≥ 18 years.
  • Performance stage 0-2.
  • Neutrophils (ANC) ≥ 1.5 x 10\^9/l
  • Platelet count ≥ 100 x 10\^9/l
  • Serum bilirubin ≤ 1.0 x upper limit of normal (ULN)
  • Serum transaminase ≤ 2.5 x ULN
  • Serum creatinine ≤ 1.5 ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)and patients with creatinine clearance \<60 mL/min should be excluded
  • Written informed consent.

You may not qualify if:

  • History of severe hypersensitivity reaction (≥grade 3) to taxol.
  • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P4503A4/5 (a one week wash-out period is necessary for patients who are already on these treatments).
  • Neuropathy grade ≥ 2.
  • Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
  • Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
  • Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
  • History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
  • Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.
  • Treatment with disulfiram (antabuse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Oncology, Aalborg Hospital

Aalborg, DK-9100, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Department of Oncology, Odense University Hospital

Odense, Denmark

Location

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Anders Jakobsen, DMSc

    Vejle Hospital

    STUDY CHAIR

  • Christine V Madsen, MD

    Vejle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 11, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

DK(4)