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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01137071
• Other study ID #: RCP-Ov-01.10
• Status: Terminated
• Phase: Phase 2
• First received: May 31, 2010
• Last updated: January 5, 2016
• Start date: April 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Recepta Biopharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• Monoclonal antibody Hu3S193
30 mg/m2 of Monoclonal antibody Hu3S193, 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.

Locations

Country	Name	City	State
Brazil	Hospital de Câncer de Barretos	Barretos	São Paulo
Brazil	Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte	Belo Horizonte	Minas Gerais
Brazil	Hospital Erasto Gaertner	Curitiba	Paraná
Brazil	Fundação Amaral Carvalho	Jaú	São Paulo
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	Núcleo de Oncologia da Bahia	Salvador	Bahia
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Recepta Biopharma

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of Progression Free Survival	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.	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.	No
Secondary	Two-year overall survival rate		2 years from the beginning of platinum-based rescue chemotherapy start date	No
Secondary	Safety	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.	From the first infusion date up to 30 days after patient's last infusion date	Yes
Secondary	1-year disease progression-free survival rate		1 year from the beginning of platinum-based rescue chemotherapy start date	No