Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

NCT01137071 | Terminated Phase 2 Results

• 1 other identifier: RCP-Ov-01.10
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 8

Brief Summary

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy

  PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

  1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.

Secondary Outcomes (57)

• 1-year Disease Progression-free Survival Rate

  1 year from the beginning of platinum-based rescue chemotherapy start date

• Two-year Overall Survival Rate

  2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.

• Safety - Vital Signs - Heart Rate

  Baseline, week 2 , week 4 and week 27

• Safety - Vital Signs - Respiratory Rate

  Baseline, week 2, week 4 and week 27

• Safety - Vital Signs - Systolic and Diastolic Blood Pressure

  Baseline, week 2, week 4 and week 27

Study Arms (1)

Monoclonal antibody hu3S193

EXPERIMENTAL

Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

Biological: Monoclonal antibody Hu3S193

Interventions

Monoclonal antibody Hu3S193 BIOLOGICAL

30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Monoclonal antibody hu3S193

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.
• Female patients of \>= 18 years of age.
• Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a complete clinical response after the first treatment of relapse with platinum-based regimen. A complete response is defined as the absence of cancer related symptoms, normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as long as not showing clear evidence of disease such as: lymph node and/or soft tissue abnormalities \<= 1.0 cm which are frequently present on the pelvis and will not be considered to be a conclusive evidence of disease.
• Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.
• The patient must have been submitted at least to hysterectomy and bilateral salpingo-oophorectomy before entering the study and must have received platinum-based chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.
• At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as treatment for the first relapse.
• All side effects from chemotherapy must have been resolved or must be grade 1.
• Interval between the last dose of the treatment with platinum that achieved clinical CR (complete response) and the first dose of Hu3S193 =\< 8 weeks.
• Karnofsky performance status \>= 70%.
• Results of laboratorial exams in the first 2 weeks before drug infusion within the following values:
• Absolute Neutrophil Count \>= 1.5 x 10x3 / mm3
• Platelet count \>= 100 x 10x3 / mm3
• Blood bilirubin \<= 2.0 mg/dL
• Aspartate aminotransaminase (AST) and Alanine aminotransferase (ALT) \<= 2.5 x upper limit of normal (ULN).
• Blood creatinine \<= 2.0 mg/dL.

You may not qualify if:

• Mucinous or clear cell histology.
• Patients must not have received Bevacizumab as part of their treatment on relapse.
• Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values \<2-fold the upper limit of normality.
• Concomitant use of systemic corticosteroids or immunosuppressive agents.
• Known CNS (central nervous system) involvement by tumor.
• Clinically significant heart disease (New York Heart Association Class III or IV).
• ECG indicating clinically significant arrhythmia.
• History of myocardial infarction within 6 months.
• Other serious diseases, (e.g.: serious infections requiring antibiotics, bleeding disorders, chronic inflammatory bowel disease, or diseases that may interfere in the obtainment of accurate study results).
• Previous treatment with a humanized murine antibody and/or fragment of such antibody.
• Previous history of tumor (excluding appropriately treated non-melanoma skin cancer or carcinoma in situ of the cervix or no evidence of disease within at least 5 years for previous breast cancer or stage I endometrial cancer).

Sponsors & Collaborators

• Recepta Biopharma: lead

Study Sites (8)

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte

Belo Horizonte, Minas Gerais, 30150-280, Brazil

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital de Câncer de Barretos

Barretos, São Paulo, 14784-700, Brazil

Location

Fundação Amaral Carvalho

Jaú, São Paulo, 17210-080, Brazil

Location

Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"

São Paulo, São Paulo, 01246-000, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

Related Publications (1)

• Smaletz O, Ismael G, Del Pilar Estevez-Diz M, Nascimento ILO, de Morais ALG, Cunha-Junior GF, Azevedo SJ, Alves VA, Moro AM, Yeda FP, Dos Santos ML, Majumder I, Hoffman EW. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi: 10.1136/ijgc-2020-002239. Epub 2021 Mar 4.

  PMID: 33664128 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Hu3S193 monoclonal antibody

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Recepta Biopharma

recepta@receptabio.com.br

55 11 3709-2140

Study Officials

• Oren Smaletz, MD

  Recepta Biopharma S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: December 29, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (8)