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A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma


OBJECTIVES:

Primary

- To estimate the proportion of patients with persistent or recurrent endometrial cancer,
who survive progression-free without going on a subsequent therapy against the disease
for at least 6 months

- To assess objective tumor response (complete or partial) in patients with recurrent or
persistent endometrial carcinoma treated with BIBF 1120.

- To determine the nature and degree of toxicity of BIBI 1120 in these patients.

Secondary

- To estimate the progression-free survival (PFS) and overall survival (OS) of patients
with persistent or recurrent endometrial cancer treated with BIBF 1120.

OUTLINE: This is a multicenter study.

Patients receive oral BIBF 1120 twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed endometrial carcinoma (original primary tumor)

- Recurrent or persistent disease that is refractory to curative therapy or
established treatments

- Patients with the following histologic epithelial cell types allowed:

- Endometrioid adenocarcinoma

- Serous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Adenocarcinoma not otherwise specified (N.O.S.)

- Mucinous adenocarcinoma

- Squamous cell carcinoma

- Transitional cell carcinoma

- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement
by clinical exam OR ≥ 20 mm by chest x-ray

- Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI

- Must have ≥ 1 "target lesion" to assess response on this protocol as defined by
RECIST

- Tumors within a previously irradiated field will be designated as "non-target"
lesions unless progression is documented or a biopsy is obtained to confirm
persistence ≥ 90 days following completion of radiotherapy

- Patients must not be eligible for a higher-priority GOG protocol, if one exists
(e.g., any active GOG phase III protocol or rare tumor protocol for the same patient
population)

- Must have had 1 prior chemotherapy regimen for the management of endometrial
carcinoma

- Chemotherapy in conjunction with primary radiation as a radio-sensitizer is
counted as a systemic chemotherapy regimen

- No history or evidence of brain metastases or active CNS disease upon physical
examination, including brain tumor

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Urine protein creatinine (UPC) ratio < 1.0 g

- Bilirubin ≤ 1.5 times ULN

- AST and ALT ≤ 3.0 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- INR ≤ 1.5 times ULN OR an in-range INR, usually between 2 and 3, if the patient is on
a stable dose of therapeutic warfarin

- PTT ≤ 1.5 times ULN

- Normal thyroid function

- History of hypothyroidism allowed provided it is well controlled with medication

- EKG must have QTc < 450 msec without evidence of serious ventricular arrhythmia
(ventricular tachycardia lasting more than 3 beats or ventricular fibrillation)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must agree to use effective contraception (two barrier methods of
birth control) prior to, during, and for 3 months after final dose of BIBF 1120

- No other invasive malignancies except non-melanoma skin cancer or curatively treated
localized cancer of the breast, head and neck, or skin with no evidence of recurrent
or metastatic disease for more than 3 years

- No serious, non-healing wound, ulcer, or bone fracture, including the following:

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 28 days

- Underlying lesions that caused the fistula or perforation in the past that have
not been corrected

- No active bleeding or pathologic conditions that carry high-risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels

- No seizures not controlled with standard medical therapy

- No clinically significant cardiovascular disease including, but not limited to, any
of the following:

- Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg
or diastolic BP > 90 mm Hg

- Myocardial infarction or unstable angina within the past 6 months

- NYHA class II-IV congestive heart failure

- Women with an ejection fraction < normal

- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation), or cardiac arrhythmias requiring anti-arrhythmic
medications except atrial fibrillation that is well controlled with
anti-arrhythmic medication

- Peripheral vascular disease ≥ grade 2 by NCI CTCAE

- History of cerebrovascular accident (CVA or stroke), transient ischemic attack
(TIA), or subarachnoid hemorrhage within the past 6 months

- No history of major thromboembolic event defined as symptomatic pulmonary embolism
(PE), recurrent asymptomatic PE, or recurrent deep venous thrombosis

- No prior thrombosis or thromboembolic event due to a known inherited coagulopathy
(i.e., antithrombin-III deficiency, protein C or protein S deficiency, Factor V
Leiden mutation presence, or prothrombin G20210A mutation)

- No serious infections (except uncomplicated urinary tract infection) requiring
systemic antibiotics or antiviral therapy, including known active hepatitis B or C
infection, or HIV infection

- No gastrointestinal or other medical disorder that would impact ingestion or
absorption of the study drug

- Patient must be able to swallow capsules

- No history of photosensitivity

- No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from recent surgery, radiotherapy, or chemotherapy

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- At least 3 weeks since prior therapy directed to the malignant tumor, including
chemotherapy and immunologic agents

- One prior cytotoxic regimen for management of recurrent or persistent disease allowed

- Patients must have NOT received any non-cytotoxic (biologic or targeted) agents, as
part of their primary treatment or for management of recurrent or persistent disease

- Non-cytotoxic (biologic or targeted) agents include (but are not limited to)
monoclonal antibodies, cytokines, and small-molecule inhibitors of signal
transduction

- Prior hormonal therapy is allowed

- There is no limit on the number of prior hormonal therapies allowed

- No prior BIBF 1120

- No prior cancer treatment that contraindicates this protocol therapy

- No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for
the treatment of endometrial cancer within the past 3 years

- Any prior radiation therapy must be completed at least 4 weeks prior to
registration

- More than 3 years since prior radiotherapy for localized cancer of the breast,
head and neck, or skin allowed provided patient remains free of recurrence or
metastatic disease

- No prior chemotherapy for any abdominal cavity or pelvis other than for the treatment
of endometrial cancer within the past 3 years

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer
allowed provided patient remains free of recurrence or metastatic disease

- No prior major surgical procedure or open biopsy within the past 28 days

- No anticipation of these procedures during the course of the study

- No minor surgical procedures, fine-needle aspirates, or core biopsies within the past
7 days

- No agents that increase photosensitivity (e.g., topical retinoids and doxycycline) 1
week before, during, and 2 weeks after administration of BIBF 1120

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival for at least 6 months

Safety Issue:

No

Principal Investigator

Don S. Dizon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Women and Infants Hospital of Rhode Island

Authority:

United States: Federal Government

Study ID:

GOG-0229K

NCT ID:

NCT01225887

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Akron General Medical CenterAkron, Ohio  44302
Franklin Square Hospital CenterBaltimore, Maryland  21237
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
MetroHealth Medical CenterCleveland, Ohio  44109
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Seattle Cancer Care AllianceSeattle, Washington  98109
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Pacific Gynecology SpecialistsSeattle, Washington  98104
Northwestern UniversityChicago, Illinois  60611
Nebraska Methodist HospitalOmaha, Nebraska  68114
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Case Western Reserve UniversityCleveland, Ohio  44106
Riverside Methodist HospitalColumbus, Ohio  43214
Indiana University Medical CenterIndianapolis, Indiana  46202
University of Texas Southwestern Medical CenterDallas, Texas  
Northwest HospitalSeattle, Washington  98133
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Lankenau HospitalWynnewood, Pennsylvania  19096
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Memorial Health University Medical CenterSavannah, Georgia  31404
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Allegiance HealthJackson, Michigan  49201
Saint Mary Mercy HospitalLivonia, Michigan  48154
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
Stony Brook University Medical CenterStony Brook, New York  11794
University of Colorado Cancer Center - Anschutz Cancer PavilionAurora, Colorado  80045
Carolinas Medical Center - NortheastConcord, North Carolina  28025
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
Saint Vincent Oncology CenterIndianapolis, Indiana  46260
Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111