A single-arm Phase II clinical study of the combination of carboplatin and weekly paclitaxel plus bevacizumab as first-line treatment in patients with epithelial ovarian cancer

• Conditions: Epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma; MedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer; MedDRA version: 9.1Level: LLTClassification code 10016180Term: Fallopian tube cancer; MedDRA version: 9.1Level: LLTClassification code 10061344Term: Peritoneal neoplasm

• Registration Number: EUCTR2008-008336-85-NL
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

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.Female patients >=18 years of age.

3.Patients with histologically confirmed and documented, high risk International Federation of Gynecologic Oncology (FIGO) Stage I–IIa (only if grade 3 / poorly differentiated) or Stage IIb–IV (any grade) epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma.
or
Clear cell carcinoma regardless of the FIGO stage (clear cell carcinoma is defined as either =50% clear cell elements present or reported as clear cell carcinoma by the local pathologist).
or
Previous early stage epithelial ovarian or fallopian tube carcinoma treated with surgery alone. If the patient has abdomino-pelvic recurrence, they are eligible to participate in the trial as long as no further surgery is planned prior to disease progression.

4.Patients should have already undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction according to the GCIG Conference Consensus Statement.1 There must be no planned surgical debulking prior to disease progression. Patients with stage III and IV disease in whom initial surgical debulking was not appropriate will still be eligible providing
•the patient has a histological diagnosis and
•debulking surgery prior to disease progression is not foreseen

5.ECOG Performance Status of 0–2.

6.Life expectancy of >= 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Non-epithelial Ovarian Cancer, including malignant mixed Müllerian tumours.
2.Ovarian tumours with low malignant potential
3.Previous systemic anti-cancer therapy for ovarian cancer.
4.History or evidence of synchronous primary endometrial carcinoma, unless all of the following criteria related to the endometrial carcinoma are met:
•stage =Ib
•no more than superficial myometrial invasion
•no lymphovascular invasion
•not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).
5.Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
6.Any prior radiotherapy to the pelvis or abdomen.
7.Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or planned during 13 months from the start of study treatment (including 12 months of bevacizumab therapy plus 4 weeks post-bevacizumab therapy).
8.Previous exposure to mouse CA-125 antibody.
9.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day).
10.Current or recent (within 10 days prior to the first study drug dose) use of full-dose oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes (except for line patency, in which case international normalized ratio [INR] must be maintained below 1.5).
11.Current or recent (within 30 days of first study dosing) treatment with another investigational drug or participation in another investigational study.
12.Planned intraperitoneal cytotoxic chemotherapy.
13.Inadequate bone marrow function: ANC: <1.5 x 109/l, or platelet count <100 x 109/l or Haemoglobin <9 g/dl. Patients may be transfused to maintain haemoglobin values =9 g/dl.
14.Inadequate coagulation parameters:
•activated partial thromboplastin time (APTT) >1.5 xULN
or
•INR >1.5
15. Inadequate liver function, defined as:
•serum (total) bilirubin >1.5 x the upper limit of normal (ULN) for the institution
•AST/SGOT or ALT/SGPT >2.5 x ULN.
16. Inadequate renal function, defined as:
•serum creatinine >2.0 mg/dl or >177 micromol/l
•urine dipstick for proteinuria >2+. Patients with >=2+ proteinuria on baseline dipstick analysis should undergo a 24-hour urine collection and must demonstrate =1g of protein in their 24-hour urine collection.
Prior or concomitant conditions or procedures:
17.History or evidence of brain metastases or spinal cord compression. A CT or MRI of the brain and/or MRI of the spinal cord must be performed within 4 weeks prior to first study treatment if the presence of metastases or compression is suspected, respectively.
18.Pre-existing peripheral neuropathy =CTC grade 2.
19.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.
20.Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly) during the study and for 6 months after the last bevacizumab administration.
21. History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular accident (CVA) / stroke or transient ischemic attack

Study & Design

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