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A Randomized, Open-label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

A Randomized, Open-label, Phase II Study Assessing the Efficacy and the Safety of Bevacizumab in Neoadjuvant Therapy in Patients With FIGO Stage IIIC/IV Ovarian, Tubal or Peritoneal Adenocarcinoma, Initially Unresectable.


Inclusion Criteria:



- Adult female patients, >/= 18 years of age

- Histologically confirmed and documented high risk stage IIIC/IV epithelial ovarian
carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma

- Patients are required to be deemed by a surgeon experienced in the management of
ovarian cancer not to be eligible for primary complete debulking surgery during a
laparoscopic procedure

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Life expectancy >/= 3 months

- Eligible for carboplatin and paclitaxel chemotherapy in accordance with local
standards

- Patient should be beneficiary of healthcare coverage under the social security system

Exclusion Criteria:

- Non-epithelial ovarian cancer, ovarian tumour with low malignant potential, or
mucinous and clear cell ovarian cancer

- Evidence of abdominal free air not explained by paracentesis or recent surgical
procedure

- Previous systemic therapy for ovarian cancer

- Previous exposure to mouse CA-125 antibody

- Current or recent treatment (within 28 days prior to Day 1, Cycle 1) with another
investigational drug or previous participation in this study

- Current or recent (within 10 days prior to first study drug dose) chronic daily
treatment with aspirin (>325 mg/day)

- Planned intraperitoneal cytotoxic chemotherapy

- Inadequate bone marrow, liver or renal function

- History of myocardial infarction, unstable angina, stroke or ischemic attack within 6
months prior to Day 1, Cycle 1

- Uncontrolled hypertension

- Clinically significant (i.e. active) cardiovascular disease (e.g. NYHA Class II or
greater congestive heart failure, aortic aneurism)

- Pre-existing peripheral neuropathy >/= CTC Grade 2

- Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell
products or other recombinant humanized antibodies or to any planned chemotherapy

- Pregnant or lactating females

- History of other clinically active malignancy within 5 years of enrolment, except for
tumours with a negligible risk for metastasis or death, such as adequately controlled
basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
or breast

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete resection rate after interval debulking surgery (IDS), defined as complete removal of all macroscopic residual tumour at IDS (Completeness of Cytoreduction Score = 0)

Outcome Time Frame:

approximately 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: ANSM - Agence Nationale de Sécurité du Médicament

Study ID:

ML28337

NCT ID:

NCT01739218

Start Date:

February 2013

Completion Date:

February 2017

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

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