Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

NCT ID: NCT00617773

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-06-30

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 in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Detailed Description

OBJECTIVES:

Primary

• To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria (Response Evaluation Criteria in Solid Tumors).

Secondary

• To determine the safety of the study drug.
• To determine the drug pharmacokinetics when administered in multiple weekly injections.

Exploratory analysis

• Clinical Benefit (objective response rate + tumor stabilization).
• Progression Free Survival (PFS).
• Duration of Response.
• Overall Survival.
• 12-month survival rate.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu3S193 IV over 1 hour once weekly in weeks 1-8. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed monthly.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer

Keywords

recurrent ovarian epithelial cancer; recurrent fallopian tube cancer; recurrent primary peritoneal cancer

Study Design

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

Study Groups

hu3S193

Group Type: EXPERIMENTAL

hu3S193

Intervention Type: BIOLOGICAL

20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

Interventions

hu3S193

20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Karnofsky performance status > 70%
• Life expectancy ≥ 12 weeks
• ANC (absolute neutrophil count) ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Serum bilirubin ≤ 2.0 mg/dL
• AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if with liver metastases)
• Creatinine ≤ 2.0 mg/dL
• Prothrombin time < 1.3 times control
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion Criteria

• NYHA (New York Heart Association) class III or IV heart disease
• Clinically significant arrhythmias by ECG
• Myocardial infarction within the past 6 months
• Any other serious illness, including any of the following:

• Severe ascites
• Severe active infections requiring antibiotics
• Bleeding disorders
• Chronic inflammatory bowel disease
• Diseases that might interfere with the collection of accurate results from this study
• Positive for human anti-human antibodies
• Prior history of tumor (excluding adequately treated nonmelanoma skin cancer or carcinoma in situ of the uterine cervix)
• Uncontrolled hypercalcemia (i.e., > 11.5 mg/dL)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from the toxic effects of any prior therapy
• No concurrent systemic steroids or immunosuppressant agents
• No more than 1 prior non-platinum-containing regimen for the treatment of platinum-resistant/refractory disease

• Patients who receive 2 or more different non-platinum-containing chemotherapy regimens for platinum-resistant/refractory disease are not eligible
• More than 4 weeks since prior and no other concurrent chemotherapy, radiotherapy, radiopharmaceuticals (e.g., ^32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy, or surgery
• More than12 weeks since prior investigational agent
• No prior treatment with a murine or humanized antibody and/or antibody fragment

• 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

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Hospital da Baleia

Minas Gerais, , Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Hospital das Clinicas FMUSP

São Paulo, , Brazil

Hospital Sirio-Libanes

São Paulo, , Brazil

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Countries

Brazil

References

Smaletz O, Diz MD, do Carmo CC, Sabbaga J, Cunha-Junior GF, Azevedo SJ, Maluf FC, Barrios CH, Costa RL, Fontana AG, Madrigal V, Wainstein AJ, Yeda FP, Alves VA, Moro AM, Blasbalg R, Scott AM, Hoffman EW. A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory ovarian, fallopian tube and primary peritoneal carcinoma. Gynecol Oncol. 2015 Aug;138(2):272-7. doi: 10.1016/j.ygyno.2015.05.023. Epub 2015 May 27.

Reference Type: DERIVED

PMID: 26026738 (View on PubMed)

Other Identifiers

RCP-Ov-01.06

Identifier Type: OTHER

Identifier Source: secondary_id

RCPOv01-06

Identifier Type: -

Identifier Source: org_study_id