Panitumumab and Pegylated Liposomal Doxorubicin to Platinum-Resistant Epithelial Ovarian Cancer with KRAS Wild-type - AGO 22 - PaLiDo
- Conditions
- Platinum-Resistant Epithelial Ovarian Cancer with KRAS Wild-typeMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancer
- Registration Number
- EUCTR2008-007799-13-AT
- Lead Sponsor
- Vejle Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 33
• Histological confirmed epithelial primary ovarian, primary fallopian or primary peritoneal cancer stage I-IV.
• A: First line treatment with first line chemotherapy with a platinum-based 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-based 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’s (evaluation of response according to CA 125 is used in this protocol).
• KRAS wild type.
• Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment):
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
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
• Prior treatment with chemotherapy or biological targeted treatment except 1. or 2. 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 diseases, hypertension).
•Clinically significant cardiovascular disease = 1 year before enrollment/randomization, including:
-Myocardial infarction or unstable angina within 6
months of randomization.
-New York Heart Association (NYHA) = Grade 2
congestive heart failure. Even if medically controlled.
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate response rate in platinum-resistant, ovarian cancer patients without KRAS mutations (KRAS wild-type) treated with pegylated liposomal doxorubicin supplemented by biological treatment with panitumumab.<br>;Secondary Objective: To investigate the PFS and OS in ovarian cancer patients treated with pegylated liposomal doxorubicin and panitumumab. Furthermore, to investigate the clinical safety and toxicity of the treatment. ;Primary end point(s): Response rates (based on GCIG modified CA-125 criteria’s (30;31))<br>RECIST criteria will not be used in this protocol.<br>
- Secondary Outcome Measures
Name Time Method