EUCTR2008-008336-85-GB
Active, not recruiting
Phase 1
A single-arm Phase II clinical study investigating the addition of bevacizumab to carboplatin and weekly paclitaxel as first-line treatment in patients with epithelial ovarian cancer - OCTAVIA
F. Hoffmann-La Roche Ltd, Pharmaceuticals Division, PDR0 sites189 target enrollmentApril 9, 2009
ConditionsEpithelial ovarian cancer, fallopian tube or primary peritoneal carcinomaMedDRA version: 9.1 Level: LLT Classification code 10033128 Term: Ovarian cancerMedDRA version: 9.1 Level: LLT Classification code 10016180 Term: Fallopian tube cancerMedDRA version: 9.1 Level: LLT Classification code 10061344 Term: Peritoneal neoplasm
DrugsAvastin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
- Sponsor
- F. Hoffmann-La Roche Ltd, Pharmaceuticals Division, PDR
- Enrollment
- 189
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
- •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).
- •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
- •See protocol for further details.
- •5\.ECOG Performance Status of 0–2\.
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.
Outcomes
Primary Outcomes
Not specified
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