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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Recepta Biopharma
ClinicalTrials.gov Identifier:
NCT01137071
First received: May 31, 2010
Last updated: March 21, 2014
Last verified: March 2014

May 31, 2010
March 21, 2014
April 2011
June 2015   (final data collection date for primary outcome measure)
Increase of Progression Free Survival [ Time Frame: From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first. An average of 16.5 months is expected. ] [ Designated as safety issue: No ]
PFS is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Improvement in Progression free survival (PFS) [ Time Frame: 5 years (since the beginning of the study) ] [ Designated as safety issue: No ]

PFS is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period. Disease progression is defined by GCIG criteria that are based on the occurrence of new lesions but it may also be measured according to the following criteria:

A. Any new lesion (measurable and non-measurable) by RECIST criteria.

B. Evidence of CA-125 equal to or above two times the upper limit of normal in two occasions with an interval of at least one week.

Complete list of historical versions of study NCT01137071 on ClinicalTrials.gov Archive Site
  • Two-year overall survival rate [ Time Frame: 2 years from the beginning of platinum-based rescue chemotherapy start date ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: From the first infusion date up to 30 days after patient's last infusion date ] [ Designated as safety issue: Yes ]
    Vital signs and adverse events will be assessed throughout the study treatment. Patients will be closely followed regarding adverse events for a period of up to 30 days after the last intravenous application of investigational product, until adverse events are resolved or until they begin a new treatment. After the 30-day period, the investigator may report the adverse events that in his/her opinion are related to the investigational product.
  • 1-year disease progression-free survival rate [ Time Frame: 1 year from the beginning of platinum-based rescue chemotherapy start date ] [ Designated as safety issue: No ]
  • Two-year overall survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Two-year overall survival rate will be determined considering 2 years from the beginning of platinum-based rescue chemotherapy.
  • Treatment safety [ Time Frame: During and for up to 30 days after patient's last infusion ] [ Designated as safety issue: Yes ]
    Patients will be closely followed regarding adverse events for a period of up to 30 days after the last intravenous application of investigational product, until adverse events are resolved or until they begin a new treatment. After the 30-day period, the investigator may report the adverse events that in his/her opinion are related to the investigational product.
Not Provided
Not Provided
 
Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Biological: Monoclonal antibody Hu3S193
    30 mg/m2, 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.
    Other Name: Hu3S193
  • Biological: hu3S193
Experimental: hu3S193
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.
Interventions:
  • Biological: Monoclonal antibody Hu3S193
  • Biological: hu3S193
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
December 2015
June 2015   (final data collection date for primary outcome measure)

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 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 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 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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01137071
RCP-Ov-01.10
No
Recepta Biopharma
Recepta Biopharma
Not Provided
Study Chair: Oren Smaletz, MD Recepta Biopharma S.A.
Recepta Biopharma
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP