A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)
- Age >=18 years old.
- Have histologically/cytologically confirmed clear cell RCC.
- Previously untreated or one prior treatment with immunotherapy (one prior treatment
may be represented by single agent interferon, single agent interleukin-2 or a
combination of interferon with interleukin-2 with or without accompanying
hematological growth factors).
- Documented evidence of progressive disease in the previous 3 months. In the absence
of radiographic studies, patients may be entered on the study if they have clinical
evidence of progressive disease.
- Have at least one unidimensional measurable lesion of RCC according to the RECIST
guidelines. The following will not qualify as measurable lesions: bone,
leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis
cutis/pulmonis, abdominal masses that are not confirmed and followed by imaging
techniques, and cystic lesions.
- Be ambulatory and have a Karnofsky performance status >=70%.
- Have a life expectancy of at least 3 months.
- Give written informed consent prior to any study-specific screening procedures, with
the understanding that the consent may be withdrawn by the patient at any time
- Be willing and able to comply with the study protocol for the duration of the study.
- Woman who are pregnant or breastfeeding. Women of childbearing potential with either
a positive pregnancy test at screening or no pregnancy test. Women of childbearing
potential unless (1) surgically sterile or (2) using adequate contraceptive measures
(postmenopausal women must be amenorrheic for at least 12 months to be considered of
- Fertile male subjects not willing to use contraception and whose female partners are
not under adequate contraceptive protection.
- Known CNS metastases (if clinical suspicion of CNS metastases exists appropriate
imaging must be performed prior to study entry).
- Prior treatment with chemotherapy (there is no restriction on prior epidermal growth
factor directed therapy).
- Severe and uncontrolled cardiac or cardiovascular abnormalities.
- Severe uncontrolled intercurrent infections.
- Subjects with organ allografts.
- Any of the following abnormal screening hematological values: Hemoglobin (Hb) <9g
/dL (6 mmol/L), Neutrophils <1.5 x 10^9/L, Platelets <100 x 10^9/L.
- Blood transfusions or growth factors to aid hematological recovery within 2 weeks
prior to starting study treatment.
- Any of the following abnormal screening liver function tests: serum bilirubin >= 1.5
x upper normal limit (ULN), alanine aminotransferase (ALAT) and aspartate
aminotransferase (ASAT) >= 2.5 x ULN (unless related to liver metastases in which
case >= 5 x ULN).
- The following abnormal screening renal function tests: either a serum creatinine >
1.5 x ULN or a creatinine clearance (estimated from serum creatinine) < 40 mL/minute.
- Prior radiotherapy (except palliative).
- Participation in any investigational drug study or immunotherapy within 4 weeks
preceding treatment start.
- History of hypersensitivity to sulphonamides.
- Any concurrent or previous malignancy of a different tumor type within 5 years of
starting E7070 treatment except for adequately treated non-melanoma skin cancer or
cervical intra-epithelial neoplasia.
- Significant disease, which in the Investigator's opinion would exclude the patient
from the study.
- Surgically resectable metastatic disease.
- Legal incapacity.