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

NCT00617773 | Completed Phase 2 Results

• 2 other identifiers: RCPOv01-06RCP-Ov-01.06
• Study Type: interventional
• Target: 31
• 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 in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response

  Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125). Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

  From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).

Secondary Outcomes (4)

• Number of Participants With Adverse Events and Serious Adverse Events

  From the first dose of investigational product up to 30 days after the last dose of investigational product

• Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).

  From the first dose of investigational product up to 30 days after the last dose of investigational product

• Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.

  Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.

• Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses

  Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.

Other Outcomes (4)

• Clinical Benefit

  From start of study treatment until the end of Cycle 3 (24 weeks).

• Progression Free Survival (PFS)

  From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.

• Overall Survival

  From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.

Study Arms (1)

hu3S193

EXPERIMENTAL

Biological: hu3S193

Interventions

hu3S193 BIOLOGICAL

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

hu3S193

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recepta Biopharma: lead

Study Sites (8)

Hospital de Clinicas de Porto Alegre

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

Location

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01401-904, Brazil

Location

Hospital da Baleia

Minas Gerais, 30285-000, Brazil

Location

Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

Location

Instituto Nacional de Cancer

Rio de Janeiro, 20220-410, Brazil

Location

Hospital das Clinicas FMUSP

São Paulo, 01246-000, Brazil

Location

Hospital Sirio-Libanes

São Paulo, 01308-050, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, 05651-901, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26026738 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

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; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. Oren Smaletz, M.D., Medical Director
• Organization: Recepta Biopharma

oren.smaletz@receptabiopharma.com.br

55 11 3709-2140

Study Officials

• Oren Smaletz, MD

  Recepta Biopharma

  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: February 15, 2008
• First Posted: February 18, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 26, 2013
• Results First Posted: November 26, 2013

Record last verified: 2013-11

Locations

BR (8)