Status:
COMPLETED
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and best dose of CCI-779 and bevacizumab and to see how well they work in treating patients with metastatic or unresectable kidney cancer. Drugs used...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) and recommended dosing for the combination of CCI-779 and Bevacizumab in patients with metastatic renal cell cancer. (Phase I) I...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed metastatic or unresectable renal cell cancer
- Must have a component of conventional clear cell histology
- The following histologies are excluded:
- True papillary
- Sarcomatoid features without any clear cell component
- Chromophobe
- Oncocytoma
- Collecting duct tumors
- Transitional cell carcinoma
- Measurable disease, defined as ≥ 1 lesion ≥ 2.0 cm in the longest diameter by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- Tumor tissue (from primary tumor or metastases) available AND patient is willing to donate blood for research studies (phase II only)
- No CNS metastases by head CT scan or MRI
- Performance status - ECOG 0-2
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- No evidence of bleeding diathesis or coagulopathy
- No history of clinically significant bleeding or active bleeding
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- PT/INR ≤ 1.5
- Patients on full-dose warfarin or stable-dose low molecular weight heparin must have INR \> 1.5 but ≤ 3
- Creatinine ≤ 1.5 times ULN
- Urine protein ≤ 1+ by dipstick or urinalysis
- Urine protein \< 1,000 mg on a 24-hour urine collection
- No cerebrovascular accident within the past 6 months
- No peripheral vascular disease with claudication on \< 1 block
- No New York Heart Association class II-IV congestive heart failure
- No angina pectoris requiring nitrate therapy
- No myocardial infarction within the past 6 months
- No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 160 mm Hg and/or diastolic BP ≥ 90 mm Hg despite medication
- No cardiac arrhythmias
- No other significant cardiovascular disease
- No ongoing hemoptysis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3-4 months after study participation
- Fasting cholesterol ≤ 350 mg/dL
- Triglycerides ≤ 1.5 times ULN (may achieve using lipid lowering agents)
- No known hypersensitivity to recombinant human antibodies
- No significant traumatic injury within the past 4 weeks
- No serious or non-healing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks
- No pathological conditions that confer a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- No diabetes
- No other currently active malignancy except nonmelanoma skin cancer
- Patients are not considered to have a currently active malignancy if they have completed anticancer therapy AND are considered to be at \< 30% risk of relapse
- No other uncontrolled serious medical or psychiatric condition
- At least 4 weeks since prior biologic response modifiers for metastatic disease
- No prior bevacizumab or mTOR inhibitors
- At least 4 weeks since prior chemotherapy for metastatic disease
- Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable and/or evaluable lesion that has not been irradiated
- At least 4 weeks since prior and no concurrent radiotherapy
- Prior nephrectomy allowed
- More than 4 weeks since prior major surgery or open biopsy
- More than 1 week since prior core biopsy
- No concurrent major surgery
- At least 4 weeks (2 weeks for vascular endothelial growth factor \[VEGF\] receptor tyrosine kinase inhibitor \[RTKI\] therapy) since prior and no more than 2 therapies (phase II)
- One of these therapies must have included a RTKI agent administered for a minimum of 4 weeks
- Concurrent full-dose warfarin or low molecular weight heparin allowed provided dose is stable AND INR requirements are met
- Concurrent zoledronate for bone metastases and/or hypercalcemia allowed provided therapy was initiated prior to study entry
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00112840
Start Date
May 1 2005
End Date
September 10 2015
Last Update
February 1 2022
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792