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Sponsored by: |
Recepta Biopharma |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00617773 |
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 |
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 |
Estimated Enrollment: | 56 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
Measurable disease, including at least one measurable lesion, according to RECIST criteria or CA-125 > 2 times upper limit of normal
Disease must be considered platinum-refractory or resistant, meeting any of the following criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any other serious illness, including any of the following:
PRIOR CONCURRENT THERAPY:
No more than 1 prior non-platinum-containing regimen for the treatment of platinum-resistant/refractory disease
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 |
Study Chair: | Oren Smaletz, MD | Recepta Biopharma |
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 |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
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 |
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 |