A randomized phase II trial of standard carboplatin-based chemotherapy with or without panitumumab in platinum-sensitive recurrent ovarian cancer
- Conditions
- Platinum-sensitive recurrent ovarian cancerMedDRA version: 19.1Level: LLTClassification code 10033131Term: Ovarian carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-018849-59-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
• Female patients with pretreated epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer with histological confirmation of the tumor
• Wild-type k-ras status
• Patients must have pretreated platinum-sensitive ovarian cancer with recurrence more than 6 months after completion of a platinum-containing regimen
• Presence of at least one measurable or non-measurable disease (e.g. malignant ascites) following RECIST criteria by radiologic evaluation OR histological confirmation of recurrence by biopsy. The presence of non-measurable lesions only requires in addition a 2-fold increase of CA-125 elevation above normal lab value (confirmed by two measurements).
• No more than 2 prior treatment regimens for these epithelial cancers
• Age = 18 years
• ECOG Performance Status of 0 or 1
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin > 9.0 g/dl
- Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3
- Platelet count ? 100.000/µl
- Total bilirubin < 1,0 times the upper limit of normal
- ALT and AST < 2,5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
- Alkaline phosphatase < 4 x ULN
- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
- Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 50 ml/min.
- Magnesium = lower limit of normal; calcium = lower limit of normal
• Signed and dated informed consent before the start of specific protocol procedures.(Analysis of K-RAS mutation status)
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
• Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment.
• History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• History of HIV infection or chronic hepatitis B or C
• Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
• Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
• Prior radiological or clinical evidence of CNS metastases including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
• History of organ allograft
• Patients with evidence or history of bleeding diathesis
• Patients undergoing renal dialysis
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
• Patients in a closed institution according to an authority or court decision
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Excluded therapies and medications, previous and concomitant:
• Anticancer chemotherapy within 4 weeks prior to study entry.
• Prior anti-EGFR therapy
• Radiotherapy during study or within 4 weeks of start of study drug. (Palliative radiotherapy of non-target lesions will be allowed) and prior radiotherapy of > 25% of the bone marrow
• Major surgery within 4 weeks of start of study
• Autologous bone marrow transplant or stem cell rescue within 12 months of study
• Investigational drug therapy outside of this trial during or within 4 weeks of study entry
• Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 12 months after trial inclusion;Secondary Objective: Response rate (RR), duration of response (DR), progression-free survival (PFS), overall survival (OS), safety: explorative evaluation in relation to the findings in the reference arm with respect to efficacy and toxicity.;Primary end point(s): Progression-free survival (PFS) rate after 12 months. PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation).;Main Objective: To determine the efficacy of panitumumab plus either the carboplatin/PLD or the carboplatin/gemcitabine combination chemotherapy in k-ras wildtype ovarian cancer patients with platinum-sensitive recurrence, compared to the historical data for the same chemotherapies, which are verified by a randomised control group without the antibody.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints to be analyzed in both study arms (including<br>exploratory comparisons) are:<br>Tumor response rate<br>Duration of Response<br>Progression-free survival (PFS)<br>Overall survival (OS)<br>Toxicity/safety<br>alterations in ovarian cancer.;Timepoint(s) of evaluation of this end point: Tumor response within treatment<br>Response duration, PFS, OS on event<br>Toxicity/safety (with special focus on skin toxicity)