The purpose of this study is to determine if ramucirumab given as monotherapy is effective in the treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma.
Current chemotherapies used to treat ovarian cancer participants include doxorubicin, topotecan, and paclitaxel, to mention a few. Doxorubicin was studied in ovarian cancer participants that were refractory to paclitaxel and platinum-based chemotherapy agents. Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. Vascular endothelial growth factor (VEGF) is an important regulator of angiogenesis and is likely an important therapeutic target in persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. VEGF is overexpressed in ovarian tissue and may be the most important single tumor angiogenic factor. Phase 1 studies currently nearing completion with ramucirumab have demonstrated safety and tolerability at clinically relevant doses, with preliminary evidence of clinical efficacy in ovarian cancer participants. Therefore, ImClone Systems plans to conduct a Phase 2 trial to assess the safety and efficacy of ramucirumab in participants with platinum-refractory persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Participants will receive ramucirumab at 8 milligrams/kilogram (mg/kg) administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
ImClone Investigational Site
Hollywood, Florida, United States
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
Chicago, Illinois, United States
Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6)
Data presented are the percentage of participants without progressive disease (PD) or death from any cause at 6 month after first dose. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion.
Time frame: First Dose to 6 Months
Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR)
Objective response is confirmed complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion. ORR is calculated as a total number of participants with CR or PR from the start of study treatment until disease progression/recurrence or the start of new therapeutic anticancer treatment, whichever occurred first, divided by the total number of participants treated, then multiplied by 100.
Time frame: First dose to date of objective progressive disease /death or new anti-cancer therapy up to 34.6 months
Progression-Free Survival (PFS)
Defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions and/or unequivocal progression of non-target lesion and/or new lesion. For participants who had no PD or death or had started new therapeutic anticancer treatment, PFS was censored at their last radiographic tumor assessment.
Time frame: First dose to measured progressive disease or death due to any cause up to 34.6 months
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ImClone Investigational Site
Marrero, Louisiana, United States
ImClone Investigational Site
Metairie, Louisiana, United States
ImClone Investigational Site
Baltimore, Maryland, United States
ImClone Investigational Site
Boston, Massachusetts, United States
ImClone Investigational Site
Rochester, Minnesota, United States
ImClone Investigational Site
Oklahoma City, Oklahoma, United States
ImClone Investigational Site
Houston, Texas, United States
...and 3 more locations
Overall Survival at 1 Year (OS-1)
Data presented are the percentage of participants surviving at least 12 months after first dose based on Kaplan Meier Method.
Time frame: First dose to 12 months
Overall Survival (OS)
Overall survival is defined as the time from first dose to the date of death due to any cause. For participants who were alive or were lost to follow-up, overall survival was censored on the last date the participant was known to be alive.
Time frame: First dose to death due to any cause up to 43.9 months
Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events
Data presented are the number of participants who experienced treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or 4 TEAE, or adverse events (AE) leading to discontinuation of treatment that were considered to be related to ramucirumab. A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
Time frame: First dose to 30 months