BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer
The main purpose of this study is to see if BIBF 1120 can increase the number of women with bevacizumab resistant, persistent, or recurrent epithelial ovarian cancer who do not progress for at least six months.
Fallopian Tube Cancer
Drug: BIBF 1120
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of BIBF 1120 in the Treatment of Bevacizumab-Resistant, Persistent, or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma|
- Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]To assess the activity of BIBF 1120 as measured by the proportion of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Objective Tumor Response via RECIST 1.1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]To determine the proportion of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.
- Duration of Progression-Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]To characterize the duration of progression-free survival and overall survival; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.
- Objective Tumor Response Based on GCIG CA-125 Criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]To determine the proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria.
- VEGF Levels Correlated With Treatment Outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]To measure baseline levels of VEGF and correlate with treatment outcome
- Additional Growth Factor Correlation with Treatment Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment
- Coagulation and Endothelial Cell Activation Markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]To measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict thrombotic or bleeding risks related to treatment
- Adverse Event Frequency and Severity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: BIBF 1120
BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy.
Drug: BIBF 1120
PO 200mg BID
Ovarian cancer patients with platinum-resistant and refractory disease have the lowest response rates to relapse chemotherapy: various chemotherapeutic agents, such as paclitaxel, liposomal doxorubicin, topotecan, docetaxel, platinum, etoposide, ifosfamide, gemcitabine, and vinorelbine are available but result in response rates of 7-40%. Unfortunately, relapse therapy is not curative and treatment is only palliative. Recently two phase II trials demonstrated that anti-angiogenic therapy with bevacizumab alone or in combination with chemotherapy in women with recurrent disease had response rates ranging from 16-24% with an acceptable toxicity profile. However, resistance can develop to VEGF inhibition. Therefore other novel anti-angiogenic agents, such as BIBF 1120, should be evaluated in the treatment of ovarian cancer.
|Contact: Beatrice Z Nelson, RN, BSN, OCNemail@example.com|
|Contact: Jennifer Mewshaw, RN, BSN, MSfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Cancer Institute||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Beatrice Z Nelson, RN, BSN, OCN|
|Contact: Jennifer Mewshaw, RN, MSN, MS|
|Principal Investigator: Angeles A Secord, MD|
|Sub-Investigator: Andrew Berchuck, MD|
|Sub-Investigator: Laura J Havrilesky, MD|
|Sub-Investigator: Fidel A Valea, MD|
|Sub-Investigator: Paula S Lee, MD|
|Sub-Investigator: Stephanie Gaillard, MD, PhD|
|Principal Investigator:||Angeles A Secord, MD||Duke University|