Brief Title
Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Official Title
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
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 as a consolidation therapy
for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube
cancer.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
Secondary Outcome
1-year Disease Progression-free Survival Rate
Condition
Fallopian Tube Cancer
Intervention
Monoclonal antibody Hu3S193
Study Arms / Comparison Groups
Monoclonal antibody hu3S193
Description: Monoclonal antibody 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
29
Start Date
April 2011
Completion Date
June 2015
Primary Completion Date
June 2015
Eligibility Criteria
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 (tumor marker) 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 (complete response) 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 (central nervous system) 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).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Oren Smaletz, MD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01137071
Organization ID
RCP-Ov-01.10
Responsible Party
Sponsor
Study Sponsor
Recepta Biopharma
Study Sponsor
Oren Smaletz, MD, Study Chair, Recepta Biopharma S.A.
Verification Date
January 2017