Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Recepta Biopharma

Status and phase

Completed

Phase 2

Conditions

Primary Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Biological: hu3S193

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617773

RCPOv01-06

RCP-Ov-01.06 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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 (Response Evaluation Criteria in Solid Tumors).

Secondary

To determine the safety of the study drug.
To determine the drug pharmacokinetics when administered in multiple weekly injections.

Exploratory analysis

Clinical Benefit (objective response rate + tumor stabilization).
Progression Free Survival (PFS).
Duration of Response.
Overall Survival.
12-month survival rate.

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.

Enrollment

31 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 (Cancer Antigen-125) > 2 times upper normal limit
- 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 (Central Nervous System) involvement by tumor

PATIENT CHARACTERISTICS:

Inclusion criteria:

Karnofsky performance status > 70%
Life expectancy ≥ 12 weeks
ANC (absolute neutrophil count) ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum bilirubin ≤ 2.0 mg/dL
AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 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 (New York Heart Association) 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