Recurrent Epithelial Ovarian Cancer
Conditions
Keywords
recurrent epithelial ovarian cancer
Brief summary
Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes.
Interventions
DRUGCatumaxomab
Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter: 1. 10 µg on day 0 2. 20 µg on day 3 3. 50 µg on day 7 4. 150 µg on day 10
Sponsors
JSehouli
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer * Recurrent ovarian cancer disease * Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST * Radiologically and cytologically confirmed malignant ascites possible to puncture * Life expectancy ≥ 12 weeks * Age ≥ 18 years * ECOG performance status at least 1 * No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug * Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent * Non-childbearing potential or negative pregnancy test
Exclusion criteria
* known brain metastases * Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases) * Any investigational product within 2 weeks prior to first administration of catumaxomab * In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis): not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens | Approximately 5 months after start of treatment per patient | Feasibility of close sequential combination of catumaxomab and established chemotherapy regimens defined by rate of patients with at least 4 chemotherapy cycles following 4 applications of catumaxomab within 20 days as described in the scope of this clinical trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy | Approximately 2.5 years after start of study | Percentage of patients who can receive all 4 applications of catumaxomab within 20 days and who are able and committed to receive further mono chemotherapy |
| Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application | Approximately 2.5 years after start of study | Percentage of patients who can start chemotherapy after a maximum of 4-7 days after last catumaxomab application |
| Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy | Approximately 2.5 years after start of study | Percentage of patients with no signs of malignant ascites at time of progression or change of therapeutic strategy |
| Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter) | Approximately 2.5 years after start of study | Puncture-free interval (defined as paracentesis-free interval after last catumaxomab application/ removal of catheter) |
| Time to progression (TTP) according to RECIST and/or CA-125 response rate | Approximately 2.5 years after start of study | Time to progression (TTP) according to RECIST and/or CA-125 response rate |
| Number and severity of adverse events as a measure of safety and tolerability | Approximately 2.5 years after start of study | Overall safety evaluation, including cytokine related toxicities (safety score catumaxomab * number and severity of adverse events * number of patients with AEs * occurrence of cytokine release related symptoms * hospitalization frequency and duration * changes in clinically relevant laboratory values (hematology, clinical chemistry, coagulation, and urinalysis) |
| To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy | Approximately 2.5 years after start of study | To assess treatment free interval to subsequent therapy (defined as duration of the interval between last chemotherapy application and start of next chemotherapy |
| To assess PFS according to RECIST and/or CA-125 response rate, OS | Approximately 2.5 years after start of study | To assess PFS according to RECIST and/or CA-125 response rate, OS |
| To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire | Approximately 2.5 years after start of study | To assess quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire |
| Potential predictive clinical factors for response to catumaxomab | Approximately 2.5 years after start of study | Analysis of potential predictive clinical factors for response to catumaxomab (e.g. amount of ascites, histology, relative lymphocyte count) |
| Overall response rate (ORR) defined as patients with complete or partial response and duration of response (according to RECIST and/or CA-125 response) | Approximately 2.5 years after start of study | Overall response rate (ORR) and duration of response (according to RECIST and/or CA-125 response) of second or third or fourth line chemotherapy and compare with historical data |
Countries
Germany
Outcome results
None listed