Panitumumab and Pegylated Liposomal Doxorubicin for Platinum-Resistant Epithelial Ovarian Cancer With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-type
- Histologically confirmed epithelial primary ovarian, primary fallopian or primary
peritoneal cancer. Stage I-IV.
- A: First line treatment with a platinum containing regimen with either
progression or no response during 1.line chemotherapy, or relapse within 6
months after end of 1. line chemotherapy, OR
- B: Patients receiving second line with a platinum containing regimen with either
progression or no response during second line chemotherapy, or relapse within 6
months after end of second line chemotherapy
- Maximum two prior lines of chemotherapy (both platinum-based)
- Age ≥ 18 years.
- Performance status 0-2.
- Measurable disease by CA125 GCIG criteria
- KRAS wild type
- Adequate bone marrow function, liver function, renal function and coagulation
parameters (within 7 days prior to randomization):
- WBC ≥ 3.0 x 109/l or neutrophils (ANC)≥ 1.5 x 109/l
- Platelet count ≥ 100 x 109/l
- Hemoglobin ≥ 9.7 g/dl (6 mmol/L)
- Serum bilirubin ≤ 1.5 x UNL
- Serum transaminases ≤ 2.5 x UNL in absence of liver metastases, or ≤ 5xUNL in
presence of liver metastases
- Serum creatinine ≤ 1.5 x UNL
- Magnesium ≥ lower limit of normal
- Calcium ≥ lower limit of normal
- Written informed consent
- Prior treatment with chemotherapy or biological targeted treatment except 1. line
chemotherapy with platinum or combination platinum/taxane (bevacizumab allowed as
part of the 1. line treatment).
- Patients who have received (or are planning to receive) treatment with any other
investigational agent, or who have participated in another clinical trial within 28
days prior to entering this trial.
- Pregnant or breast-feeding or planning to become pregnant within 6 months after end
of treatment. For fertile women a negative pregnancy test at screening is mandatory.
- Fertile patients not willing to use acceptable and safe methods of contraception
during and for 6 months following treatment
- Other present or previous malignancy except curatively treated cervical cancer,
non-melanotic skin cancer or other cancer with minimal risk of relapse.
- CNS metastasis
- History of any chronic medical or psychiatric condition or laboratory abnormality
that are not medically controlled or in the opinion of the Investigator may increase
the risks associated with study drug administration. (e.g. diabetes, cardiac
- Clinically significant cardiovascular disease ≤ 1 year before
- Myocardial infarction or unstable angina within 6 months of randomization.
- New York Heart Association (NYHA) ≥ Grade 2 congestive heart failure. Even if
- Poorly controlled cardiac arrhythmia despite Medication (patients with
rate-controlled atrial fibrillation are eligible)
- Uncontrolled hypercalcemia (calcium level outside the upper limit of normal;
antihypercalcemic treatment is allowed).
- Allergy to the ingredients of the study medication or to Staphylococcus Protein A
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial
lung disease on baseline chest CT scan.