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

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ClinicalTrials.gov Identifier: NCT01837251
Recruitment Status : Active, not recruiting
First Posted : April 23, 2013
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
ARCAGY/ GINECO GROUP
ANZGOG
Scottish Gynaecological Cancer Study Group
Information provided by (Responsible Party):
AGO Research GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Platinum-sensitive Ovarian Cancer Drug: Carboplatin Drug: PLD Biological: Bevacizumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Actual Study Start Date : May 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
No Intervention: Control Arm
Patients receive bevacizumab 15 mg/kg iv on day 1 followed by gemcitabine 1000mg/m² iv on day 1 & 8 and carboplatin AUC4 iv on day 1 every 3 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
Experimental: Research Arm
Patients receive bevacizumab 10 mg/kg iv on day 1 & 15 followed by PLD 30mg/m² iv on day 1 carboplatin AUC4 iv on day 1 every 4 weeks for up to 6 cycles in the absence of progression disease or unacceptable toxicities. Patients then continue to receive bevacizumab 15 mg/kg iv every 3 weeks until progression disease or unacceptable toxicities.
Drug: Carboplatin
Drug: PLD
Biological: Bevacizumab



Primary Outcome Measures :
  1. investigator-determined progression-free survival [ Time Frame: every 12 weeks until progression or up to 30 months (whichever occurs first) ]

Secondary Outcome Measures :
  1. biological progression-free survival by serum CA 125 [ Time Frame: every 3 weeks until progression or up to 30 months (whichever occurs first) ]
  2. Health related Quality of Life (QoL) [ Time Frame: Baseline and then every 12 weeks until investigator-determined progresssion-free survival and thereafter at every visit for th 5-years follow-up or death (whichever occurs first) ]
  3. Safety and Tolerability, i.e. type, frequency, severity and duration o adverse reactions [ Time Frame: every 3 weeks, 30 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later) ]
  4. Overall Survival [ Time Frame: every 3 weeks during treatment with bevacizumab, thereafter every 6 months; for up 30 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837251


  Show 193 Study Locations
Sponsors and Collaborators
AGO Research GmbH
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
ARCAGY/ GINECO GROUP
ANZGOG
Scottish Gynaecological Cancer Study Group
Investigators
Study Chair: Jacobus Pfisterer, PhD MD AGO Study Group

Additional Information:
Responsible Party: AGO Research GmbH
ClinicalTrials.gov Identifier: NCT01837251     History of Changes
Other Study ID Numbers: AGO-OVAR 2.21 / ENGOT ov-18
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018

Keywords provided by AGO Research GmbH:
Ovarian Carcinoma
Bevacizumab
Gemcitabine
PLD
pegylated liposomal doxorubicin
Carboplatin
best therapeutic index
progression-free survival

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Immune System Diseases
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Bevacizumab
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs