SCCA Gynecologic Cancer Clinical Trials

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.

• 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

• 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