A study of bevacizumab plus chemotherapy versus chemotherapy alone in patients with ovarian cancer.

• Conditions: Platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer; MedDRA version: 16.1Level: PTClassification code 10061344Term: Peritoneal neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: 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: EUCTR2009-011400-33-NL
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-29
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 361

Inclusion Criteria

1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with the study requirements.
2. Patients =18 years of age with histologically confirmed and documented disease. The following histological types are eligible:
• adenocarcinoma NOS
• clear cell adenocarcinoma
• endometriod adenocarcinoma
• malignant Brenner's tumour
• mixed epithelial carcinoma
• mucinous adenocarcinoma
• serous adenocarcinoma
• transitional cell carcinoma
• undifferentiated carcinoma.
3. Patients must have platinum-resistant disease (defined as progression within <6
months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy).
4. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria and require chemotherapy treatment.
5. ECOG PS 0–2.
6. Life expectancy of greater than or equal to 12 weeks.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 228
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 133

Exclusion Criteria

1. Patients whose disease was refractory to their previous platinum treatment.
2. Non-epithelial, including malignant mixed Müllerian tumours.
3. Ovarian tumours with low malignant potential.
4. History of other clinically active malignancy within 5 years of enrollment
5. Previous treatment with >2 anticancer regimens.
6. Any prior radiotherapy to the pelvis or abdomen.
7. Surgery (incl. open biopsy) within 4 wks prior to the start of study, or anticipation of the need for major surgery during study treatment.
8. Minor surgical procedures within 24 hours prior to first study treatment.
9. Previous exposure to murine CA-125 Ab (only applicable to those patients with non-measurable disease by RECIST).
10. Current or recent chronic daily treatment with aspirin (>325 mg/day).
11. Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.
12. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
13. Inadequate bone marrow function: ANC: <1.5x10E9/l, or platelet count <100x10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values >9 g/dl.
14. Inadequate coagulation parameters: aPTT >1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5 - 2.5 x ULN), or INR >1.5.
15. Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the
institution; alkaline phosphatase, AST/SGOT or ALT/SGPT >2.5 x ULN (or 5 x ULN in the presence of liver metastases).
16. Inadequate renal function, defined as serum creatinine >2.0mg/dl or >177µmol/l or calculated creatinine clearance <40ml/min for patients intended to be treated with topotecan. urine dipstick for proteinuria >2+. Patients with =2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate =1 g of protein in the 24-hour urine. Alternatively, proteinuria testing can be performed according to local
standards.
17. History or evidence upon physical/ neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
18. Symptomatic CNS metastasis
19. Pre-existing peripheral neuropathy =CTC grade 2 for those patients planned to receive paclitaxel.
20. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start).
21. Women of childbearing potential not using highly-effective, hormonal or nonhormonal means of contraception (i.e. intrauterine contraceptive device) during
the study and for 6 months after the last dose of study medication.
22. History or evidence of thrombotic or hemorrhagic disorders; including CVA/stroke or TIA or sub-arachnoid haemorrhage within =6 months prior to the first study treatment.
23. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100
mmHg despite antihypertensive therapy) or clinically significant (i.e. active cardiovascular disease, including: myocardial infarction or unstable angina within =6 months prior to the first study treatment; NYHA grade II or greater CHF;
serious cardiac arrhythmia requiring medication (with the exception of atrial
fibrillation or paroxysmal supraventricular tachycardia); peripheral vascular disease >grade 3.
24. LVEF defined by MUGA/ECHO below

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified