Status:
TERMINATED
Doxorubicin + BIBF 1120 in Patients for Ovarian Cancer
Lead Sponsor:
Hoosier Cancer Research Network
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to determine whether BIBF 1120 can be safely combined with pegylated liposomal doxorubicin (phase I), and to determine the clinical activity of the combination in patients...
Detailed Description
OUTLINE: This is a phase I/II multi-center study. Phase I: All patients will receive a fixed dose of pegylated liposomal doxorubicin (Doxil) of 40 mg/m2 administered IV every 28 days. The dose of BI...
Eligibility Criteria
Inclusion
- Platinum-resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression while on platinum) disease.
- Measurable disease as defined by RECIST v1.1 criteria on screening testing
- Be ≥18 years of age at the time of providing written informed consent for participation.
- Give written, informed consent for participation in the protocol.
- Must consent to correlative blood sample collections.
- Be at least 4 weeks from last treatment to allow recovery from prior toxicity to a Grade 1 or less.
- The following exceptions are allowed: hormonal therapy - 1 week wash-out; radiation therapy - 3 week wash-out; weekly chemotherapy - 3 week wash-out
- Patients coming off experimental therapy with biological agents with long half lives (e.g., antibodies) not expected to cause myelotoxicity should be off treatment for at least 4 weeks.
- Negative serum pregnancy test within 14 days prior to the study entry and be practicing an effective form of contraception if hysterectomy and/or oophorectomy was not part of the prior treatment
Exclusion
- Prior therapy with pegylated liposomal doxorubicin or doxorubicin.
- Prior therapy with BIBF 1120.
- Prior anti-angiogenic therapy with tyrosine kinase inhibitors (e.g. sorafenib, sunitinib, others). Note: Prior therapy with bevacizumab is allowed, provided that at least 3 months have elapsed since the last dose of bevacizumab.
- Grade 2 or greater neuropathy, at time of registration.
- Active cancer within the last 5 years, with the exception of superficial skin cancer (basal cell or squamous cell skin carcinoma), carcinoma in situ of the cervix, Stage I endometrial cancer with less than 50% invasion of the myometrium, or other adequately treated Stage I or II cancer in complete remission.
- Presence of active infection requiring antibiotic treatment, at time of registration.
- Presence of uncontrolled serious medical condition or psychiatric illness as determined by the treating physician, at time of registration.
- Known history of immune deficiency and be receiving combination anti-retroviral therapy
- Known or clinically manifest brain metastases, as progressive neurologic dysfunction may develop, that would confound the evaluation of neurologic and other adverse events.
- Presence of gastrointestinal disorders or abnormalities that would influence the absorption of the study drug.
- Presence of uncontrolled hypertension, arrhythmia, congestive heart failure or angina, at time of registration. Patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms.
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infection disease or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- Major injuries within the past 4 weeks prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
- History of clinically significant hemorrhagic or thromboembolic event in the past 6 months
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01485874
Start Date
November 1 2011
End Date
December 1 2015
Last Update
February 15 2022
Active Locations (2)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
University of Wisconsin
Madison, Wisconsin, United States, 53705