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

NCT ID: NCT01137071

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-06-30

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.

Detailed Description

This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monoclonal antibody hu3S193

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.

Group Type: EXPERIMENTAL

Monoclonal antibody Hu3S193

Intervention Type: 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.

Interventions

Monoclonal antibody Hu3S193

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.

2. Female patients of >= 18 years of age.

3. 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.

4. Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.

5. 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.

6. At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as treatment for the first relapse.

7. All side effects from chemotherapy must have been resolved or must be grade 1.

8. Interval between the last dose of the treatment with platinum that achieved clinical CR (complete response) and the first dose of Hu3S193 =< 8 weeks.

9. Karnofsky performance status >= 70%.

10. 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.
• Prothrombin time < 1.3 x control

11. Expected survival >= 12 months.

12. Patients must be willing to participate and be able to comply with the protocol throughout the study.

Exclusion Criteria

1. Mucinous or clear cell histology.

2. Patients must not have received Bevacizumab as part of their treatment on relapse.

3. Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values <2-fold the upper limit of normality.

4. Concomitant use of systemic corticosteroids or immunosuppressive agents.

5. Known CNS (central nervous system) involvement by tumor.

6. Clinically significant heart disease (New York Heart Association Class III or IV).

7. ECG indicating clinically significant arrhythmia.

8. History of myocardial infarction within 6 months.

9. 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).

10. Radiotherapy treatment, radiopharmaceuticals (e.g. 32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy or surgery within 4 weeks before the first administration of investigational product fail to recover from toxic effects of any of these therapies within 6 weeks prior to study inclusion.

11. Exposure to any investigational product within 4 months prior to study inclusion.

12. Previous treatment with a humanized murine antibody and/or fragment of such antibody.

13. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Recepta Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oren Smaletz, MD

Role: STUDY_CHAIR

Recepta Biopharma S.A.

Locations

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Fundação Amaral Carvalho

Jaú, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 33664128 (View on PubMed)

Other Identifiers

RCP-Ov-01.10

Identifier Type: -

Identifier Source: org_study_id