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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

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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

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.

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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase of Progression Free Survival

Outcome Description:

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.

Outcome 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.

Safety Issue:


Principal Investigator

Oren Smaletz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Recepta Biopharma S.A.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

December 2015

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms