Ovarian CancerPhase 2NCT03188159
Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer
A Phase 2 study testing Vinorelbine in people with Ovarian Cancer and Fallopian Tube Cancer, run by National University Hospital, Singapore at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jul 2017to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
- Have an ECOG performance status of ≤ 2.
- 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.
- 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.
- Able to tolerate IV medication.
- Life expectancy greater than 6 months
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne
Linda Mileshkin, A/Prof, (03) 8559 5000, Emaillinda.mileshkin@petermac.org
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 164119
David SP Tan, 65 6779 5555, david_sp_tan@nuhs.edu.sg
About this study
Official 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)
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.
Read the detailed description
Background Therapeutic Information In ovarian cancer, several single agent phase II trials of vinorelbine in recurrent OC have shown variable response rates of 3 - 30%. However, previous studies have involved "all-comers" and no reported trials have selected patients based on confirmed pure HGSOC or a biomarker of relevance. Preclinical studies suggest that genes involved in microtubule dynamics, are significantly over-expressed in C5 tumours. Importantly, increased sensitivity was demonstrated of C5-like cell lines to tubulin depolymerising agents like vincristine and vinorelbine compared with microtubule stabilizing agents like paclitaxel. Subsequent studies on patient derived xenograft (PDX) models of C5 HGSOC (including platinum resistant models) showed responses for more than 50 days when treated with vinorelbine, providing preclinical proof that vinorelbine may be an effective therapeutic option in targeting the C5 subclass of HGSOC, including in platinum resistant or refractory disease.
Risk/ Benefit of Intervention Vinorelbine is a hemisynthetic vinca alkaloid that is traditionally administered intravenously via an infusion. The mechanism of action is disruption of microtubules by their reversible binding to tubulin resulting in mitotic spindle dissolution and metaphase arrest in dividing cells. This trial will afford patients with C5 relapsed platinum resistant or refractory HGSOC additional treatment options that may potentially have greater benefit than standard chemotherapy.
Tolerability The main dose limiting toxicity associated with IV vinorelbine in lung cancer is myelosuppression with Grade 3-4 neutropenia seen in up to 46% of patients. However, the febrile neutropenia rate was low at <5%. Mild to moderate gastrointestinal toxicity was observed with nausea and vomiting being the most common adverse effect. Grade 3/4 nausea or vomiting occurred in 7% - 17% of patients and primary prophylaxis is recommended. Neurotoxicity was also reported with the use of vinorelbine. Peripheral neuropathy was observed in up to 11% of patients,and neuroconstipation was documented to affect up to 24% of patients, however most of these cases were mild, grade 1-2. A similar toxicity profile was observed in patients with platinum resistant ovarian cancer treated with vinorelbine. Leukopenia was the most common dose limiting toxicity followed by anemia, fatigue and nausea.
Aim and Objectives of the trial The purpose of this trial is to determine if targeting platinum resistant or refractory C5 high-grade serous, high grade endometrioid or undifferentiated ovarian, primary peritoneal and fallopian tube with vinorelbine can improve patient outcomes.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Being tested
- Vinorelbine
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| IV Vinorelbine | Experimental | IV Vinorelbine 25mg/m2 Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
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
Measured: 3 years
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
Measured: 3 years
Adverse event profile
To assess the adverse event profile of IV vinorelbine in this patient population
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre, Singapore, KK Women's and Children's Hospital, Australia New Zealand Gynaecological Oncology Group
- Responsible party
- Sponsor
- Investigators
- David Tan, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188159
- Sponsor's protocol ID
- GY01/05/16
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2017
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21941283McGuire 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.
PubMed 7494563ICON2: 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.
PubMed 9843101Ozols 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.
PubMed 12860964
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03188159
- Acronym / sponsor ID
- GY01/05/16
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Cancer Centre, Singapore, KK Women's and Children's Hospital, Australia New Zealand Gynaecological Oncology Group
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background Therapeutic Information In ovarian cancer, several single agent phase II trials of vinorelbine in recurrent OC have shown variable response rates of 3 - 30%. However, previous studies have involved "all-comers" and no reported trials have selected patients based on confirmed pure HGSOC or a biomarker of relevance. Preclinical studies suggest that genes involved in microtubule dynamics, are significantly over-expressed in C5 tumours. Importantly, increased sensitivity was demonstrated of C5-like cell lines to tubulin depolymerising agents like vincristine and vinorelbine compared with microtubule stabilizing agents like paclitaxel. Subsequent studies on patient derived xenograft (PDX) models of C5 HGSOC (including platinum resistant models) showed responses for more than 50 days when treated with vinorelbine, providing preclinical proof that vinorelbine may be an effective therapeutic option in targeting the C5 subclass of HGSOC, including in platinum resistant or refractory disease.
Risk/ Benefit of Intervention Vinorelbine is a hemisynthetic vinca alkaloid that is traditionally administered intravenously via an infusion. The mechanism of action is disruption of microtubules by their reversible binding to tubulin resulting in mitotic spindle dissolution and metaphase arrest in dividing cells. This trial will afford patients with C5 relapsed platinum resistant or refractory HGSOC additional treatment options that may potentially have greater benefit than standard chemotherapy.
Tolerability The main dose limiting toxicity associated with IV vinorelbine in lung cancer is myelosuppression with Grade 3-4 neutropenia seen in up to 46% of patients. However, the febrile neutropenia rate was low at <5%. Mild to moderate gastrointestinal toxicity was observed with nausea and vomiting being the most common adverse effect. Grade 3/4 nausea or vomiting occurred in 7% - 17% of patients and primary prophylaxis is recommended. Neurotoxicity was also reported with the use of vinorelbine. Peripheral neuropathy was observed in up to 11% of patients,and neuroconstipation was documented to affect up to 24% of patients, however most of these cases were mild, grade 1-2. A similar toxicity profile was observed in patients with platinum resistant ovarian cancer treated with vinorelbine. Leukopenia was the most common dose limiting toxicity followed by anemia, fatigue and nausea.
Aim and Objectives of the trial The purpose of this trial is to determine if targeting platinum resistant or refractory C5 high-grade serous, high grade endometrioid or undifferentiated ovarian, primary peritoneal and fallopian tube with vinorelbine can improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Vinorelbine | Experimental | Drug: VinorelbineIV Vinorelbine 25mg/m2 |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinorelbineVinorelbine 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). | Drug | IV Vinorelbine |
Primary outcome
Response rates
Time frame: 3 years
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 secondary outcomes
Progression free survival
Time frame: 3 years
Changes in the level of CA 125
Time frame: 3 years
Adverse event profile
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 21941283Vaughan 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.
- Background: PubMed 7494563McGuire 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.
- Background: PubMed 9843101ICON2: 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.
- Background: PubMed 12860964Ozols 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tan principal investigator
National University Hospital, Singapore
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine in people with Ovarian Cancer and Fallopian Tube Cancer, run by National University Hospital, Singapore at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David SP Tan ((65) 6779 5555, david_sp_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rates (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188159, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.