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A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS


MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV
study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as
first line treatment (in-label dose and scheduling). This is an exploratory study attempting
to identify potential prognostic clinical factors(such as hypertension) and prognostic
biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are
those expressing the changing nature of the disease in relation to the treatment or simply
the tumour progression, these are typically not inherited. Genetic biomarkers are typically
inherited and are expression of some characteristics potentially able to interfere with the
treatment effect (i.e. Pharmacogenomics).

The safety of this regimen in routine clinical practice will also be described.


Inclusion Criteria:



- Female patients ≥18 years of age.

- Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube
carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or
Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with
surgery alone.

- FIGO stage IIIB & C or IV

- ECOG Performance Status of 0-2.

- Life expectancy of at least 12 weeks.

- Signed informed consent obtained prior to initiation of any study-specific procedures
and treatment as confirmation of the patient's awareness and willingness to comply
with the study requirements.

- Availability of tumour samples for molecular analyses

Exclusion Criteria:

Cancer related

- Ovarian tumours with low malignant potential (i.e. borderline tumours)

- Previous systemic anti-cancer therapy for advanced ovarian cancer.

- History or evidence of brain metastases or spinal cord compression.

- History or evidence of synchronous primary endometrial carcinoma, unless all of the
following criteria related to the endometrial carcinoma are met:

- stage ≤Ia

- no more than superficial myometrial invasion

- no lymphovascular invasion

- not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).

- Other malignancy within the last 5 years, except for adequately treated carcinoma in
situ of the cervix or squamous carcinoma of the skin, or adequately controlled
limited basal cell skin cancer.

Other-treatment related

- Any prior radiotherapy to the pelvis or abdomen.

- Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or
planned (In this case the patient can be enrolled but the administration of
bevacizumab should be omitted at first cycle).

- Current or recent (within 10 days prior to the first study drug dose) use of
full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic
purposes (except for central venous access patency, in which case international
normalized ratio [INR] must be maintained below 1.5). Post operative prophylaxis with
low molecular weight heparin sc is allowed.

- Current or recent (within 30 days of first study dosing) treatment with another
investigational drug.

Laboratory related

- Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l or
Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9
g/dl.

- Inadequate coagulation parameters:

- activated partial thromboplastin time (APTT) >1.5 xULN 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/SGOT or ALT/SGPT >2.5 x ULN.

- Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177 micromol/l

- Proteinuria >1g in a 24-hour urine collection (to be performed only among patients
who showed a ≥3+ at urine dipstick).

Patient related

- Pregnant or lactating patients.

- History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular
accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid
haemorrhage within ≤6 months prior to the first study treatment).

- Uncontrolled hypertension (sustained systolic >150 mm Hg and/or diastolic >100 mm Hg
despite antihypertensive therapy) or clinically significant (i.e. active)
cardiovascular disease, including:

- myocardial infarction or unstable angina within ≤6 months prior to the first
study treatment

- New York Heart Association (NYHA) grade II or greater congestive heart failure
(CHF)

- serious cardiac arrhythmia requiring medication (with the exception of atrial
fibrillation or paroxysmal supraventricular tachycardia)

- peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with
activities of daily living requiring repair or revision).

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to the first study treatment.

- Non-healing wound, ulcer or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of fascial dehiscence or infection
are eligible but require three weekly wound examinations.

- Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer,
etc.), physical examination or laboratory findings that may interfere with the
planned treatment, affect patient compliance or place the patient at high risk from
treatment-related complications.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

expression of soluble and tissutal biomarkers

Outcome Time Frame:

measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient

Safety Issue:

No

Principal Investigator

Sandro Pignata, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples

Authority:

Italy: Ethics Committee

Study ID:

MITO-16 - MANGO-OV2

NCT ID:

NCT01706120

Start Date:

October 2012

Completion Date:

December 2015

Related Keywords:

  • Ovarian Cancer
  • prognostic factors
  • biologic factors
  • clinical factors
  • routine clinical practice
  • Ovarian Neoplasms

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