Phase 2
N=60
Study of Ramucirumab in Ovarian Cancer
Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00721162 ↗Enrolled (actual)
60
Serious AEs
36.7%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6) — 25.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ramucirumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-Free Survival at 6 Months (PFS-6) |
25.0 | — |
| PRIMARY Objective Response Rate (ORR): Percentage of Participants With Complete Response (CR) and Partial Response (PR) |
5.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.5 | — |
| SECONDARY Overall Survival at 1 Year (OS-1) |
48.0 | — |
| SECONDARY Overall Survival (OS) |
11.1 | — |
| SECONDARY Summary Listing of Participants Reporting Drug-Related Treatment-Emergent Adverse Events |
56; 10; 21; 4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Each participant must meet the following criteria to be enrolled in this study:
- The participant has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via a pathology report
- The participant has at least one unidimensional-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)], as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- The participant has recovered to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to Grade ≤ 2). Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. Continuation of hormone replacement therapy is permitted
- The participant has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of 3 years
- The participant has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (Participants may have received a noncytotoxic regimen as primary treatment.)
- The participant has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication
- The participant has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. [Prior radiation for localized cancer (for example, of the breast, head and neck, or skin) is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the participant remains free of recurrent or metastatic disease.]
- The participant has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer 3 years prior to the first dose of study medication, and that the participant remains free of recurrent or metastatic disease
- The participant has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication
- The participant has a suspected impending bowel obstruction, based on clinical or radiographic criteria
- The participant has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication
- The participant has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication
- The participant has received previous treatment with ramucirumab
- The participant has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication
- The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
- The participant has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarcti
Data sourced from ClinicalTrials.gov (NCT00721162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.