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Uterine Cervical NeoplasmsPhase 2NCT02009579

ENGOT-cx1/BGOG-cx1: 3 Weekly Carboplatin/Paclitaxel With or Without Nintedanib in Cervix Cancer

A Phase 2 study testing Nintedanib in people with Uterine Cervical Neoplasms, run by Belgian Gynaecological Oncology Group at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Indication: Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior radiochemotherapy or neo-adjuvant chemotherapy is allowed. Study design: This is a phase II randomized, double blind and placebo controlled trial evaluating the efficacy of Nintedanib/placebo in combination with the… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Nintedanib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
32 sitesin 4 countries
Study dates
Mar 2014to Oct 2023
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female subjects more than 18 years of age
  • Histologically or cytologically confirmed advanced ([FIGO] stage IVB), or recurrent/persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix will be eligible.
  • Prior treatment with angiogenesis inhibitors is allowed
  • Up to one prior line of chemotherapy for metastatic cervical cancer is allowed.
  • Treatment of primary disease with concomitant cisplatinum chemotherapy during radiotherapy is allowed and does not count as a line of chemotherapy for metastatic disease.
  • Treatment of primary disease with neoadjuvant chemotherapy before radical local surgery is allowed and does not count as a line of chemotherapy for metastatic disease.
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  • Treatment of primary disease with neoadjuvant chemotherapy before radical local surgery followed by adjuvant radiochemotherapy is allowed and does not count as a line of chemotherapy for metastatic disease.
  • Treatment of primary disease with neoadjuvant chemotherapy before radical local surgery followed by adjuvant radiotherapy is allowed and does not count as a line of chemotherapy for metastatic disease.
  • Life expectancy at least 3 months.
  • ECOG Performance status score of 0 or 1
  • At least one measurable lesion according to RECIST 1.1 criteria
  • Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation

Who cannot join

  • Known hypersensitivity to the trial drugs or to their excipients (including peanut or soya).
  • Brain or leptomeningeal metastases.
  • Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels.
  • Tumor infiltrating the mucosa of the bowel or bladder, or known fistulas between the tumor and the gastrointestinal or urinary tract.
  • Radiographic evidence of cavitary or necrotic tumours
  • Treatment with other investigational drugs or treatment in another clinical trial within the past 4 weeks before start of therapy or concomitantly with the trial.
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  • Therapeutic anticoagulation with drugs requiring INR monitoring (except low-dose heparin and/or heparin flush as needed for maintenance of an in-dwelling intravenous devise) or anti-platelet therapy (except for low-dose therapy with acetylsalicylic acid <325 mg per day).
  • Major injuries within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
  • History of clinically significant haemorrhagic or thromboembolic event in the past 6 months.
  • Known inherited predisposition to bleeding or thrombosis.
  • Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina within the past 6 months, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion).
  • History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months.
  • Abnormal renal, liver or bone marrow function defined as:
  • Proteinuria CTCAE grade 2 or greater
  • Creatinin > 2 ULN or GFR < 30 ml/min
  • Hepatic function: total bilirubin outside of normal limits; ALT or AST > 1.5 ULN in pts without liver metastasis. For Pts with liver metastases: total bilirubin outside of normal limits, ALT or AST > 2.5 ULN
  • Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN
  • Absolute neutrophil count ( ANC) < 1500/µl, platelets < 100000/µl, haemoglobin < 9.0 g/dl
  • Other malignancies within the past 3 years or other malignancy with recurrence in the past 3 years or with high risk of recurrence in the first year. In exception to this rule, the following malignancies may be included: non-melanomatous skin cancer (if adequately treated) , any premalignant (e.g. in situ) carcinoma, or basocellular carcinoma.
  • Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy.
  • Active or chronic hepatitis C and/or B infection or known HIV infection (based on medical file, only for Italy a mandatory screening test for HIV should be performed for all patients who did not have this test within the last 3 months before the study treatment start).
  • Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
  • Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with study participation or study drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the study.
  • Patients of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner or sexual abstinence for participating females) during the trial and for at least three months after end of active therapy.
  • Pregnancy or breast feeding, female patients must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment, if applicable.
  • Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
  • Active alcohol or drug abuse.

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

Italy11 sites

  • Centro Riferimento Oncologico

    Aviano

  • Spedali Civili

    Brescia

  • Azienda Ospedaliera Cannizzaro

    Catania

  • National Cancer Institute

    Milan

  • Istituto Nazionale Tumori-Pascale Naples

    Naples

  • Padova Istituti Oncologico Veneto

    Padova

  • University Pisa

    Pisa

  • AUSL Reggio Emilia

    Reggio Emilia

  • Poloclinico A Gemelli

    Rome

  • Mauriziano -Torino

    Torino

  • S. Anna Torino

    Torino

Other trials in Italy

Belgium10 sites

  • CHU Saint-Pierre

    Brussels

  • Institut Jules Bordet

    Brussels

  • Grand Hopital de Charleroi

    Charleroi

  • UZ Antwerpen

    Edegem

  • AZ Groeninge

    Kortrijk

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

  • CHR Citadelle

    Liège

  • Clinique et maternite St. Elisabeth

    Namur

  • Cliniques Universitaires mont godinne

    Yvoir

Other trials in Belgium

Germany6 sites

  • Charité Med Uni Berlin

    Berlin

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

  • Kliniken Essen Mitte

    Essen

  • Georg-August University Göttingen

    Göttingen

  • Medical University Greifswald

    Greifswald

  • University Tübingen

    Tübingen

Other trials in Germany

Spain5 sites

  • Hospital Provincial Reina Sofia

    Córdoba, 14004

  • H. Ramón y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Son Llatzer

    Palma Mallorca, 07198

Other trials in Spain

About this study

Official title: BGOG-cx1/ENGOT-cx1: "Randomized Double-blind Phase II Study Comparing 3-weekly Carboplatin + Paclitaxel With or Without Concomitant and Maintenance Nintedanib (NINTEDANIB) in Advanced or Recurrent Cervical Carcinoma."

Indication:

Treatment of subjects with advanced (FIGO stage IVB) or recurrent cervical cancer, prior radiochemotherapy or neo-adjuvant chemotherapy is allowed.

Read more

Study design:

This is a phase II randomized, double blind and placebo controlled trial evaluating the efficacy of Nintedanib/placebo in combination with the standard carboplatin and paclitaxel followed by Nintedanib/placebo maintenance in the treatment of patients with advanced or recurrent cervical cancer.

A total of 120 patients will be randomized between the experimental and control arm in a 1:1 ratio. Randomization will be stratified for 1previous chemotherapy for metastatic disease (yes/no) and 2disease status (Stage IVB primary versus recurrent disease).

Experimental arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or for a total maximum duration of 120 weeks.

Control arm: Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a total maximum duration of 120 weeks.

Subjects without evidence of disease progression after completion or discontinuation of the study treatment will be followed until radiographic disease progression, withdrawal of consent or death.

Being tested
Nintedanib, Placebo
Keywords
Uterine Cervical Cancer, Paclitaxel, Carboplatin, Nintedanib
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NintedanibDrug

    Also called Vargatef

    Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or for a total maximum duration of 120 weeks.

  • PlaceboDrug

    Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a total maximum duration of 120 weeks.

Study groups in NCT02009579
Study groupRoleWhat they receive
Experimental armActive comparatorNintedanib/vargatef
Receives: Drug: Nintedanib
Comparator armPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Primary objective:

    The purpose of this trial is to determine if chemotherapy (carboplatin/paclitaxel) plus Nintedanib (BIBF 1120) can improve progression free survival compared to chemotherapy (carboplatin/paclitaxel) plus placebo in patients with advanced or recurrent cervical cancer.

    Measured: 1.5 years after LPI

Secondary outcomes (4)

  1. Safety and toxicity

    Secondary objectives:

    To evaluate the safety and toxicity reported for of the combination regimen

    Measured: 5 years after LPI

  2. Overall survival

    To evaluate the response rate according to RECIST 1.1

    Measured: 5 years after LPI

  3. Patient health status

    To explore the effect of Nintedanib on patient reported health status as measured by EORTC-QOL-Cx 24 and EORTCQLQ-C30 questionnaires

    Measured: 5 years after LPI

  4. Overall survival

    To evaluate the overall survival

    Measured: 5 years after LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2021
  4. Study completionOct 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02009579
Sponsor's protocol ID
BGOG-cx1/ENGOT-cx1
Status last verified
Aug 2024
First submitted
24 Oct 2013
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nintedanib in people with Uterine Cervical Neoplasms, run by Belgian Gynaecological Oncology Group at 32 sites in 4 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 12 inclusion and 27 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: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Italy, Belgium, Germany, Spain. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 1.5 years after LPI). 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 NCT02009579.

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 7 Aug 2024.

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