Renal Cell (Kidney) Cancer
- Assure: Adjuvant Sorafenib or Sunitnib for Unfavorable Renal Carcinoma
- A Randomized Phase II Study of the Efficacy and Safety of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing as First-Line Therapy for Metastatic Renal Cell Cancer (Renal Effect Trial)
- A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Cancer
Assure: Adjuvant Sorafenib or Sunitnib for Unfavorable Renal Carcinoma
Eligibility Criteria (Prot. dated 05/09-Addendum #6):
- No history of distant metastases.
- No other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast. Subjects with other malignancies are eligible if they have been continuously disease-free for at least 5 years prior to the time of randomization.
- Subject must not have high blood pressure that cannot be controlled by medications.
- Subject must not have a pre-existing thyroid abnormality with thyroid stimulating hormone that cannot be maintained in the normal range with medication.
- HIV-positive subjects will be excluded due to possible effects on their immune system by these drugs.
- ECOG Performance status of 0-1.
- Subject must have paraffin-embedded tumor specimen available for central core review of tumor histology and other correlative studies.
- Subject must have no evidence of residual or metastatic renal cell cancer as documented on CT scans of chest, abdomen, and pelvis, all with oral and IV contrast (MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT of the chest may be substituted if subject is not able to have CT scans with intravenous contrast). Scans must be obtained within 4 weeks of randomization. Changes on CT scan that are felt to be post-surgical must be documented.
- Subject must not receive any other investigational anti-cancer agents during study participation.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.
A Randomized Phase II Study of the Efficacy and Safety of Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing as First-Line Therapy for Metastatic Renal Cell Cancer (Renal Effect Trial)
Eligiblity Criteria:
- Histologically confirmed advanced renal cell carcinoma of clear cell origin or a component of clear cell histology. Advanced disease is defined as locally recurrent disease or metastatic disease.
- Evidence of measurable disease by RECIST criteria. Bone lesions, ascites, peritoneal carcinomatosis or miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable.
- Subjects with their primary tumor in place who are appropriate surgical candidates are encouraged to have a partial or radical nephrectomy prior to enrollment.
- Resolution of all acute toxic effects of prior radiotherapy or surgical procedures.
- Adequate organ function.
- Karnofsky Performance status of at least 70%.
- Subject is not eligible if the renal cell carcinoma has no clear (conventional) cell component. Subejcts with true papillary, sarcomatoid features without any clear cell component, chromophobe, oncocytoma, collecting duct tumors or transitional cell carcinoma are not eligible.
- Prior systemic therapy of any kind for advanced renal cell carcinoma is not allowed (including immunotherapy, chemotherapy, hormonal, or investigational therapy). Prior neoadjuvant or adjuvant therapy with cytokines, IL-2 or vaccines is only permitted if it did notoccur within the preceding 12 months. Prior and concurrent bisphosphonate therapy is allowed.
- Prior therapy with targeted agents (sorafenib, sunitinib, bevacizumab, mTOR inhibotors) is not allowed.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.
A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Cancer
Eligibility Criteria (Per protocol dated 02/18/09):
- Histologically confirmed metastatic or unresectable renal cell carcinoma. Disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma.
- Subject must have measurable lesions according to RECIST criteria. Baseline measurements must be performed within 4 weeks prior to randomization. All sites of disease, both measurable and non-measurable, must be evaluated within 4 weeks prior to randomization.
- Subject must have evidence of progressive disease following treatment with a tyrosine kinase inhibitor (TKI) as assessed by the site investigator on the basis of CT scans and other appropriate clinical documentation.
- Subject must have received one (and only one) prior treatment with either Sutent or Nexavar for at least 12 weeks. Prior immunotherapy is limited to cytokine therapy with Interleukin 2 and interferon Alpha only. No other prior immunotherapy is allowed.
- No prior chemotherapy, cellular therapy, vaccine therapy or hormonal therapy is allowed.
- Subject must have ECOG Performance Status of 0-2.
- Subject must have recovered from any toxic effects of prior radiotherapy or surgical procedures within 4 weeks prior to randomization.
- Subject must not have known history of metastatic CNS disease.
- Subjects with basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast within the past 5 years are eligible only if treated with curative intent.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.