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A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Phase 3
18 Years
Not Enrolling
Recurrent Platinum-sensitive Ovarian Cancer

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Trial Information

A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Inclusion Criteria:

1. Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube
carcinoma or primary peritoneal carcinoma

2. First disease recurrence >6 months after first-line platinum-based chemotherapy

3. Patients with measurable or non-measurable disease (RECIST v1.1) or CA 125 assessable
disease (GCIG criteria) or histological proven diagnosis of relapse

4. In case of cytoreductive surgery for recurrence, patients must be able to commence
cytotoxic chemo-therapy within 8 weeks after cytoreductive surgery

5. ECOG PS 0-2

6. Absolute Neutrophil Count >= 1.5 x 10^9/L; Platelets >= 100 x 10^9/L; Hemoglobin >=
9.5 g/dL

7. Patients not receiving anticoagulant medication who have an International Normalized
Ratio <= 1.5 and an Activated ProThrombin Time <= 1.5 x ULN

8. Serum bilirubin <= 2 x ULN; Serum transaminases <= 2.5 x ULN (<= 5 x ULN in the
presence of liver metastasis)

9. Serum creatinine < 1.6 mg/dL or creatinine clearance >= 40 mL/min; Glomerular
filtration rate > 40 ml/min (estimates based on the Cockroft-Gault or Jelliffe
formula); Urine dipstick for proteinuria < 2+. If urine dipstick is >= 2+, 24 hour
urine collection must demonstrate <= 1 g of protein in 24 hours

10. Normal blood pressure or adequately treated and controlled hypertension (systolic BP
≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg)

Exclusion Criteria:

1. Ovarian tumors of low malignant potential

2. Malignancies other than ovarian cancer within 5 years prior to randomization

3. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy
or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial
treatment period

4. Any previous radiotherapy to the abdomen or pelvis

5. Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab
and its excipients, chinese hamster ovary cell products or other recombinant human or
humanised antibodies

6. Current or recent chronic use of aspirin > 325 mg/day

7. Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of

8. History of VEGF therapy related abdominal fistula or gastrointestinal perforation

9. Current, clinically relevant bowel obstruction, including sub-occlusive disease,
related to underlying disease

10. Patients with evidence of abdominal free air not explained by paracentesis or recent
surgical procedure

11. Previous Cerebro-Vascular Accident , Transient Ischaemic Attack or Sub-Arachnoid

12. Prior history of hypertensive crisis or hypertensive encephalopathy

13. Clinically significant disease, including: myocardial infarction or unstable angina
within ≤ 6 months of randomization; New York Heart Association (NYHA) >= grade 2
Congestive Heart Failure; poorly controlled cardiac arrhythmia despite medication;
peripheral vascular disease grade >= 3

14. LVEF defined by ECHO/MUGA below the institutional lower limit of normal

15. Significant traumatic injury during 4 weeks prior to randomization

16. Current brain metastases or spinal cord compression

17. History or evidence upon neurological examination of central nervous system disease

18. Non-healing wound, active ulcer or bone fracture

19. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to

20. Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic coagulation)

21. Fertile woman of childbearing potential not willing to use adequate contraception
(oral contraceptives, intrauterine device or barrier method of contraception in
conjunction with spermicidal jelly or surgically sterile) for the duration of the
trial and at least 6 months afterwards

22. Pregnant or lactating women

23. Requirement of therapeutic anticoagulation using marcumar, warfarin or PTT-prolonging

Type of Study:


Study Design:

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

Outcome Measure:

investigator-determined progression-free survival

Outcome Time Frame:

every 12 weeks until progression or up to 30 months (whichever occurs first)

Safety Issue:


Principal Investigator

Jacobus Pfisterer, MD PhD

Investigator Role:

Study Chair

Investigator Affiliation:

AGO Study Group


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AGO-OVAR 2.21 / ENGOT ov-18



Start Date:

May 2013

Completion Date:

November 2019

Related Keywords:

  • Recurrent Platinum-sensitive Ovarian Cancer
  • Ovarian Carcinoma
  • Bevacizumab
  • Gemcitabine
  • PLD
  • pegylated liposomal doxorubicin
  • Carboplatin
  • best therapeutic index
  • progression-free survival
  • Ovarian Neoplasms