Evaluation of Optimal Treatment With Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

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

NCT01837251•AGO Research GmbH

View on ClinicalTrials.gov

Summary

Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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 (either 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 Bevacizumab
•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
+13 more criteria

Locations (193)

Bankstown-Lidcombe Hospital

Bankstown, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

NCCI - Coffs Harbour Hospital

Coffs Harbour, Australia

The Townsville Hospital

Douglas, Australia

Peninsula Health - Frankston Hospital

Frankston, Australia

Andrew Love Cancer Centre Geelong

Geelong, Australia

Royal Brisbane & Women's Hospital

Herston, Australia

Royal Hobart Hospital

Hobart, Australia

St. George Hospital

Kogarah, Australia

ICON Cancer Care Centre

Milton, Australia

Key Dates

Start Date

May 1, 2013

Primary Completion Date

January 1, 2021

Completion Date

January 1, 2021

Last Updated

July 13, 2021

Enrollment

682

ACTUAL participants

Conditions

Recurrent Platinum-sensitive Ovarian Cancer

Interventions

Carboplatin

DRUG

PLD

DRUG

Bevacizumab

BIOLOGICAL