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Cancer, OvarianPhase 2NOVANCT01847677

Neoadjuvant Therapy in Advanced Ovarian Cancer With Avastin

A Phase 2 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Cancer, Ovarian, run by Grupo Español de Investigación en Cáncer de Ovario at 13 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer, Ovarian
What is being tested?
Bevacizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
13 sitesSpain
Study dates
6 May 2013to 17 May 2019
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

  • Women over 18 years old
  • Obtained informed consent, in writing and signed
  • Histological confirmation of primary peritoneal carcinoma or fallopian tube carcinoma
  • Planned interval debulking surgery
  • ECOG:0 to 2
  • Life expectancy >12 weeks

Who cannot join

  • Non-epithelial ovarian cancer, including malignant mixed Müllerian tumors.
  • Borderline ovarian tumors.
  • Administration of intraperitoneal chemotherapy planned.
  • Previous systemic anti-tumor treatment against ovarian cancer.
  • Intestinal obstruction or sub-occlusion, intestinal infiltration shown by CT scan or rectosigmoid infiltration in gynaecological examination.
  • Uncontrolled hypertension.
Show all 42Show fewer
  • Any previous radiotherapy: abdomen or pelvis.
  • Major traumatic injuries in the 4 weeks prior to the first potential dose of bevacizumab.
  • History or clinical suspicion of brain metastases or spinal cord compression.
  • History or evidence of central nervous system (CNS) disorders, unless properly treated with standard medical treatment.
  • Cerebrovascular accident (CVA), transient ischemic attack (TIA) or subarachnoid haemorrhage (SAH) in the 6 months prior to randomization.
  • Fertile women of childbearing age who are not willing to use effective contraception during the study and at least 6 months after the study.
  • Women that are breastfeeding or pregnant.
  • Prior exposure to mouse CA-125 antibody.
  • Treatment with any other experimental product, or participation in another clinical trial within 30 days prior to inclusion.
  • Malignant tumors other than ovarian cancer within the 5 years prior to randomisation, with the exception of cervical carcinoma in situ treated correctly and/or basal-cell carcinoma.
  • Known hypersensitivity to bevacizumab or any of its excipients (including Cremophor).
  • Non-healing wound, active peptic ulcer or bone fracture. Patients with healing incised granulomas by secondary intention, with no evidence of fascial dehiscence or infection can be included, but they require three weeks of wound control.
  • History or evidence of bleeding or thrombotic diathesis
  • Current or recent continued use of aspirin > 325 mg / day (within 10 days prior to randomization)
  • Current or recent use (within 10 days before the first cycle of treatment) of full doses of anticoagulants or thrombolytics administered orally or parenterally for therapeutic purposes (except for vascular permeability, in which case the INR should be kept below 1.5).
  • Clinically significant cardiovascular disease, including:
  • Myocardial infarction or unstable angina (≤ 6 months before randomization)
  • Congestive heart failure (CHF) class ≥ II of the NYHA (New York Heart Association)
  • Poorly controlled cardiac arrhythmia despite medication (may include patients with atrial fibrillation with controlled frequency)
  • Peripheral vascular disease ≥ grade 3 (i.e. symptomatic and interfering with activities or daily living [ADL] needing repair or review)
  • Pre-existing sensory or motor neuropathy, ≥ grade 2
  • Demonstration of any other neurological or metabolic dysfunction involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications
  • No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
  • Laboratory:
  • Inadequate bone marrow function:
  • ANC: <1.5 x 109/l
  • platelet count <100 x 109/l
  • Hb <9 g/dl. (Patients may be transfused)
  • Inadequate coagulation parameters: Activated partial thromboplastin time (APTT) >1.5 x ULN or INR >1.5
  • Inadequate liver function, defined as:
  • Serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution
  • AST \& ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases) or alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
  • Inadequate renal function, defined as:
  • Serum creatinine >2.0 mg/dl or >177 mol/l
  • Urine dipstick for proteinuria >2+
  • Patients with 2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate ≤1g of protein in their 24-hour urine collection

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital Clínic

    Barcelona

  • Hospital Sant Pau

    Barcelona

  • H. Reina Sofia

    Córdoba

  • ICO Girona

    Girona

  • ICO Hospitalet

    Hospitalet Del Llobregat

  • Hospital 12 de Octubre

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario Morales Meseguer

    Murcia

  • Hospital Son Llatzer

    Palma Mallorca

  • Parc Taulí

    Sabadell

  • Hospital Marqués de Valdecilla

    Santander

  • Hospital La Fe

    Valencia, Valencia, 46026

Other trials in Spain

About this study

Official title: A Randomized Phase II Multi-centric Open Label Clinical Trial to Determine the Efficacy and Toxicity of Preoperative Chemotherapy With or Without Bevacizumab in Patients With Advanced Ovarian Cancer

Recently results have shown that Bevacizumab is active both in monotherapy and in combination therapy in patients with ovarian cancer. One of our objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.

Read the detailed description

Epithelial ovarian cancer (OC) is the fourth leading cause of cancer death in women, after lung, breast and colon cancer, and it represents the most common cause of death from gynaecological malignancies. The high mortality associated with OC is due to the lack of screening tests that enable an early diagnosis, thus the majority of patients are diagnosed at advanced stages of the disease when the chances of a cure are very limited. In fact, the 5-year overall survival (OS) rate for stage III-IV OC does not exceed 20-30% in many series. The standard treatment for advanced OC is maximal cytoreductive surgery (or debulking) followed by the administration of 6 cycles of adjuvant chemotherapy with carboplatin and paclitaxel.

In recent years, a number of studies have been carried out with antiangiogenic drugs. Specifically, bevacizumab, an anti-VEGF monoclonal antibody, has been shown to be active both in monotherapy and combination therapy in patients with OC that have received multiple previous lines of chemotherapy.

One of the objectives is to evaluate whether the addition of neoadjuvant bevacizumab improves the response and whether this affects the evolution of patients.

Conditions
Cancer, Ovarian
Keywords
ovarian cancer, neoadyuvant, bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

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

Study groups in NCT01847677
Study groupRoleWhat they receive
Paclitaxel & CarboplatinActive comparator1. Preoperative treatment Cycle 1 to 4 (4 cycles every 3 weeks of chemotherapy pre-surgery) * Carboplatin AUC 6 i.v. first day * Paclitaxel 175 mg/m2 i.v. first day 2. Surgery 3. Post-Operative treatment Cycle 5 to 7 (3 cycles every 3 weeks of chemotherapy post-surgery): * Carboplatin AUC 6 i.v. first day * Paclitaxel 175 mg/m2 i.v. first day * Bevacizumab 15 mg/Kg i.v. first day1 When the chemotherapy treatment is completed, the patient will continue with maintenance bevacizumab until 15 months length treatment.
Receives: Drug: Paclitaxel; Drug: Carboplatin
Paclitaxel & Carboplatin & BevacizumabExperimental4 cycles every 3 weeks (at least 3 Bevacizumab neoadjuvant cycles): Carboplatin AUC 6 i.v. first day Paclitaxel 175 mg/m2 i.v. first day Bevacizumab 15 mg/Kg i.v. first day. b) Surgery Ovarian cancer surgery should be performed according to FIGO guidelines. c) Postoperative treatment Both arms: Cycle 5 to 7 (3 cycles every 3 weeks of chemotherapy post-surgery): Carboplatin AUC 6 i.v. first day Paclitaxel 175 mg/m2 i.v. first day Bevacizumab 15 mg/Kg i.v. first day. When the chemotherapy treatment is completed, the patient will continue with maintenance bevacizumab until 15 months length treatment.
Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Complete response rate

    Complete response rate (microscopic residual tumor included) assessed by the surgeon at laparotomy after neoadjuvant therapy.

    Measured: average 24 months

Secondary outcomes (8)

  1. Safety: toxicities and surgical complications

    Safety and tolerability of the treatment will be assessed by adverse event description: incidence, severity, time of onset, causes, and abnormal laboratory values .

    Measured: average 24 months

  2. Surgical feasibility

    rate of patients in which surgery is feasible, comparing both arms.

    Measured: average 24 months

  3. Optimal surgery rate

    rate of patients in which surgery is optimal (residual disease<1cm), comparing both arms

    Measured: average 24 months

  4. RECIST 1.1 responses and correlation with serological responses (GCIG criteria)

    It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables

    Measured: average 24 months

  5. Progression-free survival according RECIST 1.1 criteria

    tables of survival will be constructed by the Kaplan-Meier method. Mean and median, both with confidence intervals of 95%. Comparisons between groups will be made by log-rank test.

    Measured: average 24 months

  6. Overall Survival (OS)

    tables of survival will be constructed by the Kaplan-Meier method. Mean and median, both with confidence intervals of 95%. Comparisons between groups will be made by log-rank test.

    Measured: average 24 months

  7. Association between clinical response and the expression of protein biomarkers, in pre-and post-surgical plasma.

    It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables

    Measured: average 24 months

  8. Biomarkers: Epithelial-mesenchymal transition performed at C.S. Parc Taulí

    It will be assesed using descriptive statistics techniques such as frequency tables and contingency tables

    Measured: average 24 months

Timeline

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

  1. First posted7 May 2013 (estimated)
  2. Study start6 May 2013
  3. Primary completion4 Jun 2015
  4. Study completion17 May 2019

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
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847677
Sponsor's protocol ID
GEICO-1205
Other IDs
2012-003883-31
Acronym
NOVA
Status last verified
May 2019
First submitted
26 Apr 2013
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Paclitaxel and Carboplatin in people with Cancer, Ovarian, run by Grupo Español de Investigación en Cáncer de Ovario at 13 sites in Spain.

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 6 inclusion and 42 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: stopped early, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in 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. 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 was stopped early. Results are not available in the source record.

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?

Complete response rate (time frame: average 24 months). 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 NCT01847677, which also lists 1 linked publication.

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 1 Apr 2020.

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