Clinical trial · Interventional
Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission
A Phase II of Intraperitoneal Catumaxomab as a Consolidation Therapy in Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma in Second or Third Complete Clinical Disease Remission
NCT01246440CI-TRIAL-00023444completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of catumaxomab as consolidation treatment in patients with epithelial ovarian cancer in second or third complete remission.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Catumaxomab | Drug | Catumaxomab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Catumaxomab
- interventionNames
- Drug: Catumaxomab
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- 3 years
- description
- Progression-free survival per protocol is defined as the period from the commencement of the consolidation treatment (catumaxomab Day 0) and the recurrence of the disease or the last follow-up for the patients not developing a recurrence.
Secondary outcomes (10)
- measure
- Second progression-free survival (2PFS)
- timeFrame
- 3 years
- description
- In patients in second complete remission, measured from the beginning of the treatment for the first recurrence until the date of the second recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed Informed consent. * Initial histopathologic diagnosis of epithelial ovarian cancer, cancer of the fallopian tube or primary peritoneal carcinoma * Women ≥ 18 years * ECOG performance status ≤ 1 (Eastern Cooperative Oncology Groupperformance) * Initial surgical cytoreduction as primary treatment combinated with Platinum- based chemotherapy administered as part of primary therapy. Failure of the primary treatment as manifested by recurrent disease that have achieved a second or third complete response with a second or third-line chemotherapy (platinum-based or not). The complete response to the second or third-line chemotherapy is defined as non symptoms of cancer persistence, normal CA-125 (cancer antigen 125), negative medical examination, and no evidence of disease in a TAC. * At least 4 cycles of second or third-line chemotherapy must have been administered * Surgery performed at first or second relapse in conjunction with second or third-line chemotherapy is permitted. Exclusion Criteria: * Acute or chronic infection * Concomitant treatment with cancer chemo- and/or radiotherapy * Exposure to an investigational product within 28 days of first infusion * Previous treatment with murine monoclonal antibodies * Inadequate renal function: creatinine \>1.5 upper limit of normal \[ULN\] and/ or calculated creatinine clearance ≥ 50 mL/min * Inadequate hepatic function (AST, ALT, \>2.5 xULN; bilirubin \>1.5 xULN), Hypoalbuminaemia \< 3 g/dL * Platelets \<80000 cells/mm3; absolute neutrophil count (ANC) \<1000 cells/mm3, * Hb \< 8g/dL and PTT \> 2 x ULN * Patients with occlusive intestinal or symptomatic sub-occlusive intestinal within the last 30 days. * Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia * Unable or unwilling to comply fully with the protocol. * Any co-morbid disease that would increase risk of toxicity according to investigator judgment * Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures * Exposure to investigational product, cancer, chemo-or radiotherapy within the last 28 days (6 weeks for nitrosoureas or mitomycin C) before first infusion * Known or suspected hypersensitivity to catumaxomab or similar antibodies * Long-lasting steroid treatment (≥ 7 days), Patients should only be included after stepwise discontinuation and free of steroids for a minimum of 5 days
References
Publications (0)
Data not yet available
No reference posted for this study.