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SCCA Gynecologic Cancer Clinical Trials

BIBF 1120 in Recurrent or Persistent Endometrial Cancer (GOG 229-K)
A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Status Conditions Phase Study ID
Recruiting Endometrial Cancer II GOG 229-K
NCT01225887
Summary

The primary pbjective of this study is 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.


Investigator
Benjamin Greer, MD
Location    
PSOC Office 206-667-5152  
Multicare Health System, Tacoma WA 253-403-5265  
Olympic Medical Center, Sequim WA 360-683-9895  
Skagit Valley Hospital, Mt. Vernon WA 360-424-2687  
Wenatchee Valley Medical Center, Wenatchee WA 509-665-5800 x5122  
Group Health 206-225-7893  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
  • 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
Last Updated
September 11, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.