A phase II, open- label, controlled, randomized, multicenter study to evaluate the efficacy and safety of pertuzumab (Omnitarg™), a recombinant humanized antibody against HER2, in combination with carboplatin-based standard chemotherapy versus carboplatin-based standard chemotherapy alone in patients with platinum-sensitive recurrent ovarian cancer
- Conditions
- Platinum sensitive recurrent ovarian cancer
- Registration Number
- EUCTR2005-000557-30-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 148
- ECOG performance status of 0 or 1.
- Life expectancy of = 12 weeks.
- Histologically confirmed platinum-sensitive recurrent ovarian cancer, as defined by a progression-free interval of greater than 6 months after completion of a platinum-based regimen
- Only one previous regimen which must be platinum-based.
- At least one measurable lesion according to RECIST or non-measurable disease. If non-measurable disease must have an elevated CA 125 level of = 2 x ULN documented by two measurements.
- Availability of paraffin embedded tumor tissue tumor tissue sample for biomarker assessment
- Baseline LVEF = 50% (measured by echocardiography or in exceptional cases by MUGA scan).
- For women of childbearing potential, a negative pregnancy test must be available and they must use an effective method of contraception.
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
- History of CNS metastasis or with clinical evidence of CNS metastases.
- Prior radiotherapy.
- Inadequate bone marrow, liver function and renal function parameters as described in protocol.
Prior treatment with any targeted therapy.
- Prior exposure to anthracyclines as defined in protocol.
- History of congestive heart failure NYHA grade > 2, unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease.
- Patient with serious uncontrolled intercurrent illness
- Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method