Full Text View
Tabular View
No Study Results Posted
Related Studies
Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), February 2009
First Received: February 15, 2008   Last Updated: April 2, 2009   History of Changes
Sponsored by: Recepta Biopharma
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00617773
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: monoclonal antibody Hu3S193
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response as measured by RECIST criteria [ Designated as safety issue: No ]
  • Response as measured by CA-125 decline [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment safety during and for up to 30 days after completion of study treatment [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Clinical benefit (objective response rate plus tumor stabilization) [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Survival rate at 12 months [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: May 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

Secondary

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Progressive disease
    • Disease must express Lewis-Y antigen documented by immunohistochemistry in archived or fresh primary or metastatic tumor biopsies
  • Measurable disease, including at least one measurable lesion, according to RECIST criteria or CA-125 > 2 times upper limit of normal

    • Pleural effusion, ascites, bone metastases, and lesions located in previously irradiated areas are not considered measurable
  • Disease must be considered platinum-refractory or resistant, meeting any of the following criteria:

    • Platinum-refractory defined as progression during the initial platinum-based chemotherapy regimen or failure to achieve a complete response (e.g., stable disease or partial response) with evidence of progressive disease (by physical examination, radiological exams, or CA-125) during the initial platinum-based chemotherapy
    • Platinum-resistant defined as recurrence within six months of completion of the initial platinum-based regimen (primary platinum-resistance) or recurrence after six months of completion of the initial platinum-based regimen (still considered platinum-sensitive, but incurable by any approach, that will progress to a secondary platinum-resistance scenario) and failure to ≥ 1 re-induction with a platinum-based regimen (secondary platinum-resistance)
  • No high tumor burden, as assessed by the investigator
  • No rapidly progressing disease, as assessed by clinical evaluation
  • No known CNS involvement by tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Karnofsky performance status > 70%
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617773

Locations
Brazil
Hospital Sirio-Libanes Recruiting
Sao Paulo, Brazil, 01308-050
Contact: Contact Person     55-11-3155-0254        
Instituto Brasileiro De Cancerologia Toracica Recruiting
Sao Paulo, Brazil, 03102-002
Contact: Contact Person     55-11-3474-4222        
Instituto Nacional de Cancer Recruiting
Rio de Janeiro, Brazil, 20220-410
Contact: Contact Person     55-21-2276-4940        
Recepta Biopharma Recruiting
Sao Paulo, Brazil, 04533-014
Contact: Contact Person     55-113-709-2140        
Hospital Alemao Oswaldo Cruz Recruiting
Sao Paulo, Brazil, 01401-904
Contact: Jorge Sabbaga, MD, PhD     55-11-3549-0665     jsabbaga@uol.com.br    
Brazil, Minas Gerais
Biocancer Centro de Pesq e Trat de Cancer SA Recruiting
Belo-Horizonte, Minas Gerais, Brazil, 30240-060
Contact: Contact Person     55-31-3224-2030        
Sponsors and Collaborators
Recepta Biopharma
Investigators
Study Chair: Oren Smaletz, MD Recepta Biopharma
  More Information

Additional Information:
No publications provided

Responsible Party: Recepta Biopharma ( Oren Smaletz )
Study ID Numbers: CDR0000583521, RECEPTA-RCP-Ov-01.06
Study First Received: February 15, 2008
Last Updated: April 2, 2009
ClinicalTrials.gov Identifier: NCT00617773     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Antibodies, Monoclonal
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Immunoglobulins
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Ovarian Epithelial Cancer
Recurrence
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Immunologic Factors
Gonadal Disorders
Physiological Effects of Drugs
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Pharmacologic Actions
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Antibodies, Monoclonal
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009