Neoadjuvant Therapy in Advanced Ovarian Cancer With Avastin

Sponsor
Grupo Español de Investigación en Cáncer de Ovario
Study ID
NCT01847677
Phase
PHASE2
Status
Terminated

Conditions

  • Cancer, Ovarian

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
  • Paclitaxel — DRUG
  • Carboplatin — DRUG

Study Details

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.

Key Dates

First listed
May 7, 2013
Start date
May 6, 2013
Status verified
May 2019
Primary completion
Jun 4, 2015
Completion
May 17, 2019

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Paclitaxel & Carboplatin
    1. 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.
  • Experimental: Paclitaxel & Carboplatin & Bevacizumab
    4 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.

Primary Outcome Measure

Complete response rate [ Time Frame: average 24 months ]

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