GOG 229K: A Phase II Evaluation of BIBF 1120 (IND#113086) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
This trial is a multicenter, no randomization, 2-stage phase II clinical trial. The primary objective of this study is to assess the efficacy and toxicity of the study agent (BIBF-1120) in patients with recurrent or persistent endometrial cancer. The primary measures of efficacy will be objective response and whether the patient survived progression-free without going on a subsequent therapy against the disease for at least 6 months.
3.11 Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments. Histologic confirmation of the original primary tumor is required.
Patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma.
3.12 All patients must have measurable disease as defined by RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray. Lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
3.13 Patient must have at least one
* target lesion
* to be used to assess response on this protocol as defined by RECIST 1.1 (Section 8.1). Tumors within a previously irradiated field will be designated as
* lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
3.14 Patients must not be eligible for a higher priority GOG protocol, if one exists. In general, this would refer to any active GOG Phase III protocol or Rare Tumor protocol for the same patient population.
3.15 Patients must have a GOG Performance Status of 0, 1, or 2.
3.16 Patients must have normal thyroid function. Patients with a history of hypothyroidism are eligible, provided it is well controlled on medication.
3.17 Recovery from effects of recent surgery, radiotherapy, or chemotherapy
3.161 Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).
3.162 Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.
3.163 Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration.
3.164 Any prior radiation therapy must be completed at least 4 weeks prior to registration. (1/3/12)
3.17 Prior Therapy
3.171 Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer will be counted as a systemic chemotherapy regimen.
3.172 Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease. (1/3/12)
3.173 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. (1/3/12)
3.18 Patients must have adequate:
3.181 Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. Platelets greater than or equal to100,000/mcl.
3.182 Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN).
3.183 Urine Protein Creatinine: Urine protein creatinine (UPC) ratio must be < 1.0 gm. If UPC ratio > 1, collection of 24-hour urine measurement of urine protein is recommended.
UPC ratio of spot urine is an estimation of the 24 urine protein excretion x a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas:
1. [urine protein]/[urine creatinine] x if both protein and creatinine are reported in mg/dL
2. [(urine protein) x0.088]/[urine creatinine] x if urine creatinine is reported in mmol/L
3.184 Hepatic function: Bilirubin must be less than 1.5 X ULN. AST and ALT must be less than 3 X ULN. Alkaline phosphatase must be less than 2.5 X ULN. These hepatic function requirements are required irregardless of the presence of liver metastases.
3.185 Blood coagulation parameters: PT such that international normalized ratio (INR) is < 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT <= 1. times the institutional upper limit of normal.
3.186 Cardiac function: Baseline cardiac function must be within normal range defined as: EKG must have QTc < 450 msec without evidence of serious ventricular arrhythmia (ventricular tachycardia lasting more than 3 beats or ventricular fibrillation).
3.19 Patients must have signed an approved informed consent and authorization permitting release of personal health information.
3.110 Patients must meet pre-entry requirements as specified in section 7.0.
3.111 Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry. The effects of BIBF 1120 on the developing human fetus are unknown. For this reason and because anti-angiogenic agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (two barrier methods of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she is to inform her treating physician immediately. All patients must be willing to take contraception up to three months after the final dose of BIBF 1120.