Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00501644 | Chemoimmunotherapy Study for Patients With Epithelial Ovarian Cancer | PHASE2 | COMPLETED | 59 | — | — | Jan 1, 2003 | Jan 1, 2009 | Aug 7, 2012 | 1 | United States |
Per World Health Organization (WHO) Tumor Response: Complete Response (CR), Partial Response (PR) or Progressive Disease (PD). CR defined as disappearance of all target lesions, PR as \> = 30% decrease in sum of longest dimensions of target lesions with reference baseline sum longest dimensions and if CA 125 levels declined by \>50%, provided target lesion size did not increase by \>20% on imaging, and PD as \>20% increase in sum of longest dimensions of target lesions taking as references smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or \> new lesions.
| Arm | Type | Description |
|---|---|---|
| Chemoimmunotherapy | EXPERIMENTAL | GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | AUC of 5 by 1 hour IV infusion every 28 days. |
| GM-CSF (Sargramostim) | DRUG | Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy. |
| Interferon Gamma | DRUG | 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle). |
Inclusion Criteria: 1. Patients with Müllerian carcinomas (primary epithelial ovarian, primary peritoneal, or fallopian tube) who have had a response to platinum-based chemotherapy and have a chemotherapy treatment-free interval of at least 6 months. These patients are designated potentially platin...