OPSROC: Optimal therapy for women with Platinum Sensitive Ovariance Cancer.A randomised trial comparing two different chemotherapy regiments in combination with bevacizumab in women with ovarian cancer relapsing over 6 months from first line therapy.
- Conditions
- Patients with platinum-sensitive recurrent ovarian cancerMedDRA version: 17.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004125-24-GB
- Lead Sponsor
- Greater Glasgow Health Board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 654
(1) Written informed consent
(2) Females >= 18 years
(3) Histologically confirmed diagnosis of:
- epithelial ovarian carcinoma (including mixed Mullerian tumours) or
- fallopian tube carcinoma or
- primary peritoneal carcinoma
All FIGO stages, histological grades and types are allowed
(4) First disease recurrence > 6 months after first-line platinum-based chemotherapy, no prior chemotherapy in the recurrent setting is allowed.
(5) Patient with measurable or non-measurable disease (according to RECIST v1.1) or CA125 assessable disease (according to GCIG criteria) or histological proven diagnosis or relapse
(6) In case of cytoreductive surgery for recurrent, patients must be able to commence cytotoxic chemotherapy within 8 weeks after cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if the investigator decides to start chemotherapy within 4 weeks after debulking surgery for recurrent disease.
(7) ECOG performance status (PS) 0-2
(8) Life expectancy > 3 months
(9) Adequate bone marrow function (within 28 days prior to randomisation):
- ANC >= 1.5 x 109
- Platelets >= 100 x 109
- Haemoglobin >= 9.5 g/dL
(10) Adequate coagulation parameters (within 28 days prior to randomisation:
- Patients not receiving anticoagulant medication who have an INR <=1.5 and an aPTT <= 1.5 x ULN
(11) Adequate liver function (within 28 days prior to randomisation):
- serum bilirubin (BR) <= 2 x ULN
- serum transaminases <= 2.5 x ULN (<= 5 x ULN in the presence of liver metastasis)
(12) Adequate renal function (within 28 days prior to randomisation):
- serum creatinine < 1.6 mg/dL or creatiine clearance >= 40 mL/min
- Glomerular filtration rate > 40 ml/min based on the Cockcroft-Gault or Jelliffe formula are sufficient)
- Urine dipstick for proteinuria < 2+
(13) Normal blood pressure or adequately treatment and controlled hypertension (systolic BP <= 140mmHg and/or diastolic BP <= 90mmHg)
Please see protocol for full details on inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
(1) Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
(2) Ovarian tumors of low malignant potential (i.e. borderline tumors)
(3) Malignancies other than ovarian cancer within 5 years prior to randomisation, except for adequately treated:
- carcinoma in situ of the cervix
- and/or basal cell skin cancer
- and/or non-melanomatous skin cancer
- and/or carcinoma in situ of the breast
- and/or endometrial carcinoma (FIGO stage <= 1A)
Patients may have received previous adjuvant chemotherapy for other malignancies e.g. breast or colorectal carcinoma if diagnosed over 5 years ago before randomisation with no evidence of subsequent recurrence
(4) Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormone replacement therapy is permitted as are steroidal antiemetics)
(5) Any previous radiotherapy to the abdomen or pelvis
(6) Treatment with any other investigational agent, or participation in another clinical trial testing a drug within the past 30 days before randomisation
(7) Known hypersensitivity to used chemotherapeutic agents in this trial and bevacizumab and its excipients, chinese hamster ovary cell products or other recombinant hum or humanised antibodies
(8) Current or recent (within 10 days prior to randomisation) chronic use of aspirin >325 mg/day
(9) Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowed for the fact that bevacizumab can be omitted for the first cycle of chemotherapy). It is strongly recommended that an interval of 7 days is left between the insertion of any central venous access devices (CVADs) and the onset of bevacizumab treatment.
(10) Any planned surgery during the treatment period plus 4 additional weeks to allow for bevacizumab clearance
(11) History of VEGF therapy related abdominal fistula or gastrointestinal perforation
(12) Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
(13) Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
(14) Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomisation
(15) Prior history of hypertensive crisis or hypertensive encephalopathy. Uncontrolled hypertension (sustained elevation of systolic blood pressure > 140 mmHg and/or diastolic >90 mmHg despite antihypertensive therapy).
(16) Clinically significant (i.e. active) cardiovascular disease, including:
- myocardial infarction or unstable anginal within <= 6 months of randomisation
- New York Heart Association (NYHA) >=grade 2 Congestive Heart Failure (CHF)
- poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
- peripheral vascular disease grade >= 3 (i.e. symptomatic and interfering with activities of daily living (ADL) requiring repair or revision)
(17) Left ventricular ejection fraction (LVEF) defined by ECHO/MUGA below the institutional lower limit of normal
(18) Significant traumatic injury during 4 weeks prior to randomisation
(19) Current brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomisation) in case of sus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary efficacy outcome measure for this clinical trial is investigator-determined progression-free survival;Secondary Objective: (1) Overall survival<br>(2) Biological Progression-free Survival (PFSbio) by serum CA125 assessed according to GCIG criteria<br>(3) Quality of Life (QoL) assessed by EORTC QLQ-C30 and QLQ-OV28<br>(4) Safety and tolerability;Primary end point(s): The primary outcome measure is Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: Tumor assessments will include gynecological examination and cross sectional imaging (by CT, or MRI in case of contrast allergy) of the pelvis and abdomen and (by X-ray or CT scan,) of the chest every 12 weeks. Evaluation will be based on RECIST v.
- Secondary Outcome Measures
Name Time Method