Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.

Further Study Information

OBJECTIVES:

Primary

• To evaluate the efficacy of monoclonal antibody Hu3S193 in women with platinum-resistant/refractory ovarian, fallopian tube, or primary peritoneal cancer, based on RECIST criteria.

Secondary

• To determine the safety of the study drug.

• To determine the drug pharmacokinetics when administered in multiple weekly injections.

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

• Progressive disease

• Disease must express Lewis-Y antigen documented by immunohistochemistry in archived or fresh primary or metastatic tumor biopsies

• Measurable disease, including at least one measurable lesion, according to RECIST criteria or CA-125 > 2 times upper limit of normal

• Pleural effusion, ascites, bone metastases, and lesions located in previously irradiated areas are not considered measurable

• Disease must be considered platinum-refractory or resistant, meeting any of the following criteria:

• Platinum-refractory defined as progression during the initial platinum-based chemotherapy regimen or failure to achieve a complete response (e.g., stable disease or partial response) with evidence of progressive disease (by physical examination, radiological exams, or CA-125) during the initial platinum-based chemotherapy

• Platinum-resistant defined as recurrence within six months of completion of the initial platinum-based regimen (primary platinum-resistance) or recurrence after six months of completion of the initial platinum-based regimen (still considered platinum-sensitive, but incurable by any approach, that will progress to a secondary platinum-resistance scenario) and failure to ≥ 1 re-induction with a platinum-based regimen (secondary platinum-resistance)

• No high tumor burden, as assessed by the investigator

• No rapidly progressing disease, as assessed by clinical evaluation

• No known CNS involvement by tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status > 70%

• Life expectancy ≥ 12 weeks

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Serum bilirubin ≤ 2.0 mg/dL

• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if with liver metastases)

• Creatinine ≤ 2.0 mg/dL

• Prothrombin time < 1.3 times control

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

Exclusion criteria:

• NYHA class III or IV heart disease

• Clinically significant arrhythmias by ECG

• Myocardial infarction within the past 6 months

• Any other serious illness, including any of the following:

• Severe ascites

• Severe active infections requiring antibiotics

• Bleeding disorders

• Chronic inflammatory bowel disease

• Diseases that might interfere with the collection of accurate results from this study

• Positive for human anti-human antibodies

• Prior history of tumor (excluding adequately treated nonmelanoma skin cancer or carcinoma in situ of the uterine cervix)

• Uncontrolled hypercalcemia (i.e., > 11.5 mg/dL)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from the toxic effects of any prior therapy

• No concurrent systemic steroids or immunosuppressant agents

• No more than 1 prior non-platinum-containing regimen for the treatment of platinum-resistant/refractory disease

• Patients who receive 2 or more different non-platinum-containing chemotherapy regimens for platinum-resistant/refractory disease are not eligible

• More than 4 weeks since prior and no other concurrent chemotherapy, radiotherapy, radiopharmaceuticals (e.g., ^32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy, or surgery

• More than12 weeks since prior investigational agent

• No prior treatment with a murine or humanized antibody and/or antibody fragment

Trial Contact Information

Trial Lead Organizations/Sponsors

Recepta Biopharma

Oren Smaletz

Study Chair

Brazil
	Minas Gerais
	Hospital da Baleia
		Contact Person	Ph: 55-31-3213-7669
	Porto Alegre
	Hospital de Clinicas de Porto Alegre
		Contact Person	Ph: 55-51-3359-8619
	Hospital Sao Lucas da PUCRS
		Carlos H. Barrios, MD	Ph: 55-51-3320-3039
			Email: chbe@via-rs.net
	Rio de Janeiro
	Instituto Nacional de Cancer
		Contact Person	Ph: 55-21-2276-4953
	Sao Paulo
	Hospital Alemao Oswaldo Cruz
		Jorge Sabbaga, MD, PhD	Ph: 55-11-3549-0392
			Email: jsabbaga@uol.com.br
	Hospital das Clinicas FMUSP
		Contact Person	Ph: 55-11-3893-4780
	Hospital Israelita Albert Einstein
		Oren Smaletz	Ph: 55-11-3747-0724
	Hospital Sirio-Libanes
		Contact Person	Ph: 55-11-3155-4207
	Recepta Biopharma
		Oren Smaletz	Ph: 55-11-3709-2140

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00617773
Information obtained from ClinicalTrials.gov on January 02, 2012

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