Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer

NCT03188159 | Unknown Phase 2

• 1 other identifier: GY01/05/16
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (3)

• Progression free survival

  3 years

• Changes in the level of CA 125

  3 years

• Adverse event profile

  3 years

Study Arms (1)

IV Vinorelbine

EXPERIMENTAL

IV Vinorelbine 25mg/m2

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

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).

IV Vinorelbine

Eligibility Criteria

• Age: 21 Years - 99 Years
• Gender Eligibility Details: The disease is only contracted by females who have the organs (fallopian tube and ovaries).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent
• 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
• Have histological confirmation of high-grade serous or high-grade endometrioid or undifferentiated tumour of the primary peritoneum, fallopian tube cancer or ovary
• Molecular subtyping by Nanostring technology must confirm C5 subtype on primary ovarian surgical sample or a biopsy of recurrent disease
• 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
• Measurable disease by RECIST criteria (version 1.1).
• 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.
• Age ≥ 18 years of age (Age ≥ 21 years of age for Singapore sites)
• 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

You may not qualify if:

• Women who are pregnant or nursing
• Previous exposure to vinorelbine
• Patients known to be hypersensitive to vinorelbine or any vinca alkaloids previously
• Persistent toxicities (≥ Common Terminology Criteria for Adverse Event (CTCAE) v4.0 grade 1) caused by previous cancer therapy, excluding alopecia
• Have active, acute, or chronic clinically significant infections or bleeding.
• Have active angina pectoris, stroke, myocardial infarction, or any other pre-existing uncontrolled cardiovascular condition within the last 6 months.
• Have additional uncontrolled serious medical or psychiatric illness.
• Require therapeutic doses of anti-coagulation with warfarin or warfarin derivatives. However, treatment with low molecular weight heparin (LMWH) is allowed.
• Known symptomatic CNS metastases. Treated brain metastatis that are stable for more than ≥4 weeks are allowed.
• Psychiatric disorders that would hinder compliance with study protocol
• 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.
• Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 at the time of registration
• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National Cancer Centre, Singapore: collaborator
• KK Women's and Children's Hospital: collaborator
• Australia New Zealand Gynaecological Oncology Group: collaborator

Study Sites (2)

Peter MacCallum Cancer Centre

Melbourne, Australia

RECRUITING

National University Hospital

Singapore, 164119, Singapore

RECRUITING

Related Publications (4)

• 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.

  PMID: 21941283 BACKGROUND

• 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. doi: 10.1056/NEJM199601043340101.

  PMID: 7494563 BACKGROUND

• 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.

  PMID: 9843101 BACKGROUND

• 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. doi: 10.1200/JCO.2003.02.153. Epub 2003 Jul 14.

  PMID: 12860964 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• David Tan

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David SP Tan

CONTACT

(65) 6779 5555; david_sp_tan@nuhs.edu.sg

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: March 16, 2017
• First Posted: June 15, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); SG (1)