Catumaxomab as a Consolidation Therapy in Patients With Ovarian Cancer in Second or Third Clinical Disease Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01246440|
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Catumaxomab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||December 2014|
Catumaxomab: 4 intraperitoneal infusions of catumaxomab over 11 days administered in a period of 3 hours through an intraperitoneal catheter with the following dosage: 1) 10 µg on Day 0. 2) 20 µg on Day 3. 3) 50 µg on Day 7. 4) 200 µg on Day 10.
- Progression-free survival (PFS) [ Time Frame: 3 years ]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.
- Second progression-free survival (2PFS) [ Time Frame: 3 years ]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.
- Third progression-free survival (3PFS) [ Time Frame: 3 years ]In patients in third complete remission, measured from the beginning of the treatment for the second recurrence until the date of the third recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.
- Progression-free survival per protocol [ Time Frame: 3 years ]Measured from the date of the beginning of the study treatment (catumaxomab Day 0) until the recurrence of the disease, or the date of the last follow-up when the patient does not develop a recurrence of the disease.
- First progression-free survival [ Time Frame: 3 years ]Which has to be recorded retrospectively, measured from the date of the initial treatment for the ovarian cancer (neoadjuvant chemotherapy or cytoreductive surgery) until the date of the first recurrence of the disease.
- Duration of the treatment-free interval [ Time Frame: 3 years ]Measured from the date of the administration of the last dose of catumaxomab until the date of the beginning of the following salvage treatment.
- Overall survival rate [ Time Frame: 3 years ]Measured from the date of the first administration of the study treatment (catumaxomab Day 0) until the death of the patient.
- Incidence, intensity and causalidad of every adverse event. [ Time Frame: 3 years ]The incidence, intensity and possible causality of every adverse event (AE). AEs will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 4.0.
- Therapeutic compliance [ Time Frame: 3 years ]Compliance and percentage of patients being given the 4th dose of catumaxomab in accordance with the treatment plan, Day 10.
- The level of cells involved in the immune response [ Time Frame: 3 years ]The level of cells involved in the immune response, including sub-populations of the T lymphocytes, B lymphocytes, "natural killer" cells, and antigen-processing cells measured in a sample of ovarian cancer (optional study)
- Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab [ Time Frame: 3 years ]Interval between the administration of the last dose of chemotherapy and the beginning of the treatment with catumaxomab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246440
|Institut Català d'Oncologia de Girona|
|Girona, Barcelona, Spain, 17007|
|Corporació Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital Universitario 12 de Octubre|
|Madrid, Madrdi, Spain, 28041|
|Hospital Universitario Fundación Alcorcon|
|Alcorcon, Madrid, Spain, 28922|
|Hospital de la Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Gregorio Marañon|
|Madrid, Spain, 28007|
|Madrid, Spain, 28033|
|Hospital Universitario Ramon y Cajal|
|Madrid, Spain, 28034|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Hospital Son Dureta|
|Mallorca, Spain, 07014|
|Hospital Jose Maria Morales Meseguer|
|Murcia, Spain, 30008|
|Hospital Universitario de Valdecilla|
|Santander, Spain, 39008|
|Hosptial Clinico Universitario de Santiago de Compostela|
|Santiago de Compostela, Spain, 15706|
|Hospital Universitario La Fe de Valencia|
|Valencia, Spain, 46009|
|Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Hospital Miguel Servet|
|Zaragoza, Spain, 50009|
|Study Chair:||Ana Oaknin, Dra.||Hospital de la Vall d'Hebron|
|Study Chair:||Antonio Gonzalez, Dr.||M.D. Anderson|
|Principal Investigator:||Miguel Beltran, Dr.||Institut Calatà d'Oncologia de Girona|
|Principal Investigator:||Yolanda García, Dra.||Corporació Sanitaria Parc Tauli|
|Principal Investigator:||Andrés Póveda, Dr.||Instituto Valenciano de Oncología|
|Principal Investigator:||Ana Santaballa, Dra.||Hospital Universitario La Fe de Valencia|
|Principal Investigator:||Mª Elena García, Dra.||Hospital José Maria Morales Meseguer|
|Principal Investigator:||Andrés Redondo, Dr.||Hospital Universitario La Paz|
|Principal Investigator:||Ana Herrero, Dra.||Hospital Miguel Servet|
|Principal Investigator:||Juan Fernando Cuevas, Dr.||Hospital Clínico Universitario de Santiago de Compostela|
|Principal Investigator:||Arantxa Gonzalez, Dra.||Hospital Son Dureta|
|Principal Investigator:||Eva Guerra, Dra.||Hospital Universitario Ramon y Cajal|
|Principal Investigator:||Jesus García, Dr.||Hospital Universitario Fundación Alcorcon|
|Principal Investigator:||Jose Angel Arranz, Dr.||Hospital Gregorio Marañon|
|Principal Investigator:||Ana de Juan, Dra.||Hospital Universitario de Valdecilla|
|Principal Investigator:||Antonio Casado, Dr.||Hospital Clínico San Carlos|
|Principal Investigator:||César Mendiola, Dr.||Hospital Universitario 12 de Octubre|