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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03188159




Registration number
NCT03188159
Ethics application status
Date submitted
16/03/2017
Date registered
15/06/2017
Date last updated
29/03/2018

Titles & IDs
Public title
Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer
Scientific title
Phase II Study of Intravenous Vinorelbine in Patients With Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer (VIP)
Secondary ID [1] 0 0
GY01/05/16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vinorelbine

Experimental: IV Vinorelbine - IV Vinorelbine 25mg/m2


Treatment: Drugs: Vinorelbine
Vinorelbine 25 mg/m2 intravenously on day-1 and day-8 of a 3 week cycle to commence following confirmation of eligibility into the study for a maximum of 12 months, until disease progression, intolerable toxicity or withdrawal of patient consent (whichever event occurs first).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response rates - To determine the activity of vinorelbine as defined by response rates when patients with recurrent platinum resistant or refractory C5 high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal or fallopian tube cancer are treated with IV vinorelbine based on RECISTv1.1
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Progression free survival - To assess progression free survival when patients with recurrent platinum resistant C5 high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal and fallopian tube cancer are treated with IV vinorelbine
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Changes in the level of CA 125 - A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA 125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Adverse event profile - To assess the adverse event profile of IV vinorelbine in this patient population
Timepoint [3] 0 0
3 years

Eligibility
Key inclusion criteria
1. Provided written informed consent

2. Patients must have platinum resistant or refractory HGSOC; defined as progressive
disease by imaging = 6 months from last date of most recent platinum-based therapy or
rising CA-125 based on GCIG criteria

3. Have histological confirmation of high-grade serous or high-grade endometrioid or
undifferentiated tumour of the primary peritoneum, fallopian tube cancer or ovary

4. Molecular subtyping by Nanostring technology must confirm C5 subtype on primary
ovarian surgical sample or a biopsy of recurrent disease

5. Patients must not have received more than 3 prior chemotherapy regimens, which may
include chemotherapy, biologics or other targeted therapies (this does not include
maintenance treatment or hormonal therapy) for platinum resistant disease

6. Measurable disease by RECIST criteria (version 1.1).

7. At time of registration, if the patient has had previous treatment it must have been
at least 28 days since major surgery or radiation therapy; 28 days from any other
previous anti-cancer therapy including biologics; 14 days since hormone therapy.
Patients must have recovered to = grade 1 from their treatment-related events with the
exception of alopecia.

8. Age = 18 years of age (Age = 21 years of age for Singapore sites)

9. Have clinically acceptable laboratory screening results within certain limits
specified below:

- AST and ALT = 2.5 times upper limit of normal (ULN)

- Total bilirubin = ULN

- Creatinine = 1.5 x UL

- Absolute neutrophil count = 1500 cells/mm

- Platelets = 100,000/mm3

- Hemoglobin = 9.0 g/dl

10. Have an ECOG performance status of = 2.

11. Women of child-producing potential must agree to use effective contraceptive methods
prior to study entry, during study participation, and for at least 30 days after the
last administration of study medication.

12. Have the ability to understand the requirements of the study, provide written informed
consent, abide by the study restrictions, and agree to return for the required
assessments.

13. Able to tolerate IV medication.

14. Life expectancy greater than 6 months
Minimum age
21 Years
Maximum age
99 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or nursing

2. Previous exposure to vinorelbine

3. Patients known to be hypersensitive to vinorelbine or any vinca alkaloids previously

4. Persistent toxicities (= Common Terminology Criteria for Adverse Event (CTCAE) v4.0
grade 1) caused by previous cancer therapy, excluding alopecia

5. Have active, acute, or chronic clinically significant infections or bleeding.

6. Have active angina pectoris, stroke, myocardial infarction, or any other pre-existing
uncontrolled cardiovascular condition within the last 6 months.

7. Have additional uncontrolled serious medical or psychiatric illness.

8. Require therapeutic doses of anti-coagulation with warfarin or warfarin derivatives.
However, treatment with low molecular weight heparin (LMWH) is allowed.

9. Known symptomatic CNS metastases. Treated brain metastatis that are stable for more
than =4 weeks are allowed.

10. Psychiatric disorders that would hinder compliance with study protocol

11. History of other malignancies within the past 5 years except for curatively treated
skin BCC or SCC or cervical carcinoma in situ. Patients who have had curatively
treated breast cancer, with completion of adjuvant chemotherapy more than three years
before are allowed.

12. Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 at
the time of registration

13. Subjects known to be HIV positive or with active and untreated Hepatitis B or
Hepatitis C infection. Patients with controlled Hepatitis B or Hepatitis C infection
on treatment with antiviral medication are allowed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
National University Hospital, Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Cancer Centre, Singapore
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
KK Women's and Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australia New Zealand Gynaecological Oncology Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase II study in patients with recurrent platinum resistant or refractory C5
high-grade serous, endometrioid or undifferentiated ovarian, primary peritoneal or fallopian
tube cancer. All patients with high-grade serous, endometrioid or undifferentiated primary
peritoneum, fallopian tube or ovarian cancer will be eligible to be screened for this trial
and will be required to sign a pre-screening consent form.
Trial website
https://clinicaltrials.gov/show/NCT03188159
Trial related presentations / publications
Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.
McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med. 1996 Jan 4;334(1):1-6.
ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer. ICON Collaborators. International Collaborative Ovarian Neoplasm Study. Lancet. 1998 Nov 14;352(9140):1571-6.
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, Mannel RS, DeGeest K, Hartenbach EM, Baergen R; Gynecologic Oncology Group. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Sep 1;21(17):3194-200. Epub 2003 Jul 14.
Public notes

Contacts
Principal investigator
Name 0 0
David Tan
Address 0 0
National University Hospital, Singapore
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David SP Tan
Address 0 0
Country 0 0
Phone 0 0
(65) 6779 5555
Fax 0 0
Email 0 0
david_sp_tan@nuhs.edu.sg
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03188159