Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT01637532
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2012-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2012-04-15', 'studyFirstSubmitQcDate': '2012-07-08', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The feasibility (NCI-CTCv4.0) to combine carboplatin and PLD or doxorubicin with tocilizumab as well as with tocilizumab and Peg-Intron', 'timeFrame': 'two years', 'description': 'The safety (NCI-CTCv4.0)and efficacy (immune-monitoring)of the new combination will be measured .'}], 'secondaryOutcomes': [{'measure': 'The effect of chemo-immunotherapy on the immune system', 'timeFrame': 'two years', 'description': 'Study the effect of chemo-immunotherapy on the immune system by assessing changes in plasma signature (eg IL6, IL8, VEGF, CRP) dendritic cell phenotype and T- and B-cell responses to known tumor antigens in ovarian cancer (eg NY-ESO, p53), antibodies to antigens associated with immunogenic cell death (CRT, HMGB1) and in tumor tissue by gene array'}, {'measure': 'The relation between anti-tumor immunity and clinical outcome', 'timeFrame': 'two years', 'description': 'Study the relation between anti-tumor immunity and clinical outcome (response (RECIST 1.1), progression free survival (PFS) and overall survival(OS))'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '26216383', 'type': 'DERIVED', 'citation': 'Dijkgraaf EM, Santegoets SJ, Reyners AK, Goedemans R, Wouters MC, Kenter GG, van Erkel AR, van Poelgeest MI, Nijman HW, van der Hoeven JJ, Welters MJ, van der Burg SH, Kroep JR. A phase I trial combining carboplatin/doxorubicin with tocilizumab, an anti-IL-6R monoclonal antibody, and interferon-alpha2b in patients with recurrent epithelial ovarian cancer. Ann Oncol. 2015 Oct;26(10):2141-9. doi: 10.1093/annonc/mdv309. Epub 2015 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron).\n\nThis study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven epithelial ovarian cancer\n* Progression of disease or relapse after previous therapy with platinum\n* Measurable disease (RECIST 1.1) or elevated CA125 \\> 2 times the upper normal limit (UNL) within 3 months and confirmed\n* Age ≥18 years\n* WHO performance status 0-2\n* Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l\n* Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT\n\n * 2.5 x UNL (\\<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL\n* Adequate renal function: the calculated creatinine clearance should be\n\n * 50 mL/min\n* Survival expectation \\> 3 months\n* Patients must be accessible for treatment and follow-up\n* Written informed consent according to the local Ethics Committee requirements\n\nExclusion Criteria:\n\n* Chemotherapy within past 3 months\n* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix\n* Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias\n* Known hypersensitivity reaction to any of the components of the treatment\n* Pregnancy or lactating\n* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent\n* Infection with tuberculosis and hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT01637532', 'acronym': 'PITCH', 'briefTitle': 'Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.', 'orgStudyIdInfo': {'id': 'PITCH trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Carboplatin/Caelyx', 'interventionNames': ['Drug: Carboplatin and Caelyx or doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Carboplatin/Caelyx or doxorubicin plus Tocilizumab', 'interventionNames': ['Drug: tocilizumab and interferon alpha 2-b', 'Drug: Carboplatin and Caelyx or doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Carboplatin/Caelyx or doxorubicin plus Tocilizumab plus Peg-Intron', 'interventionNames': ['Drug: tocilizumab and interferon alpha 2-b', 'Drug: Carboplatin and Caelyx or doxorubicin']}], 'interventions': [{'name': 'tocilizumab and interferon alpha 2-b', 'type': 'DRUG', 'description': 'During first three chemotherapy cycles, tocilizumab and/or Peg-Intron are added.\n\nTocilizumab is given in a dose-escalation scheme (1,2,4,8mg/kg n=3) and Peg-Intron is adminstered subcutaneously 1.0ug/kg', 'armGroupLabels': ['Group 2', 'Group 3']}, {'name': 'Carboplatin and Caelyx or doxorubicin', 'type': 'DRUG', 'description': 'Standard chemotherapeutic care given in every arm as standard care. A total of 6 cycles is the aim.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'G Blecourt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Groningen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'J.R. Kroep', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}