Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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.
Fallopian Tube Cancer
Primary Peritoneal Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE II TRIAL OF Hu3S193 THERAPY FOR PATIENTS WITH PLATINUM REFRACTORY OR PLATINUM RESISTANT EPITHELIAL OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER|
- Best Overall Response [ Time Frame: From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks). ] [ Designated as safety issue: No ]
Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).
Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
- Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]A listing of all adverse events is located in the Reported Adverse Event module.
- Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%). [ Time Frame: From the first dose of investigational product up to 30 days after the last dose of investigational product ] [ Designated as safety issue: Yes ]Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.
- Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses. [ Time Frame: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1. ] [ Designated as safety issue: No ]Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
- Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses [ Time Frame: Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1. ] [ Designated as safety issue: No ]Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
- Clinical Benefit [ Time Frame: From start of study treatment until the end of Cycle 3 (24 weeks). ] [ Designated as safety issue: No ]
The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.
Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.
The evaluation of target and non-target lesions is described at the Outcome Measure titled "Best Overall Response". CR: Complete Response; PR: Partial Response; SD: Stable Disease.
- Progression Free Survival (PFS) [ Time Frame: From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks. ] [ Designated as safety issue: No ]Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.
- Overall Survival [ Time Frame: From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks. ] [ Designated as safety issue: No ]Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.
- 12-Month Survival Rate [ Time Frame: 12 months from the start of study treatment. ] [ Designated as safety issue: No ]Rate of patients alive 12 months after starting therapy with the investigational product.
|Study Start Date:||May 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
- 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).
- To determine the safety of the study drug.
- To determine the drug pharmacokinetics when administered in multiple weekly injections.
- 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.
|Hospital de Clinicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil, 90035-903|
|Hospital da Baleia|
|Minas Gerais, Brazil, 30285-000|
|Hospital Sao Lucas da PUCRS|
|Porto Alegre, Brazil, 90610-000|
|Instituto Nacional de Cancer|
|Rio de Janeiro, Brazil, 20220-410|
|Sao Paulo, Brazil, 01308-050|
|Hospital Israelita Albert Einstein|
|Sao Paulo, Brazil, 05651-901|
|Hospital das Clinicas FMUSP|
|Sao Paulo, Brazil, 01246-000|
|Hospital Alemao Oswaldo Cruz|
|Sao Paulo, Brazil, 01401-904|
|Study Chair:||Oren Smaletz, MD||Recepta Biopharma|