Platinum-sensitive recurrent ovarian cancer MedDRA version: 19.1 Level: LLT Classification code 10033131 Term: Ovarian carcinoma System Organ Class: 100000004864
Conditions
Sponsors
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints to be analyzed in both study arms (including exploratory comparisons) are: Tumor response rate Duration of Response Progression-free survival (PFS) Overall survival (OS) Toxicity/safety alterations in ovarian cancer.;Timepoint(s) of evaluation of this end point: Tumor response within treatment Response duration, PFS, OS on event Toxicity/safety (with special focus on skin toxicity) | — |
Countries
Germany
Contacts
Public ContactCRO
ClinAssess GmbH
Outcome results
None listed