Clinical trial · Interventional
CCI-779 and Bevacizumab in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase I/II Trial of CCI-779 and Bevacizumab in Stage IV Renal Cell Carcinoma
NCT00112840CI-TRIAL-00056274completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving CCI-779 together with bevacizumab may kill more tumor cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| CCI-779 | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCI-779 and bevacizumab
- description
- Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CCI-779 and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Phase II patients receive CCI-779 and bevacizumab as in phase I at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
- interventionNames
- Drug: CCI-779
- Drug: Bevacizumab
Primary outcomes (2)
- measure
- Dose-limiting Toxicity (DLT) (Phase I)
- timeFrame
- Patients observed a minimum of 4 weeks (one full course). The maximum number of cycles observed was 16 cycles.
- description
- For this protocol, dose limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment in the first four weeks of combination therapy, and meeting the following criteria: * Grade 4 Absolute neutrophil count (ANC) for 5+ days. * Grade 4 anemia or thrombocytopenia of any duration. * Serum Creatinine 2 times baseline or 2x upper limit of normal if baseline levels not normal. * Any other non-hematologic grade 3 or higher as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 3.0, except fatigue and grade 3 Hypertension that is will be controlled with oral medication. * Grade 3 triglycerides will be a DLT for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy. The maximum tolerated dose level (MTD) will be defined as the highest safely tolerated dose where 1 or 0 out of 6 patients experience DLT with the next higher dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 entryReferences
Publications (0)
Data not yet available
No reference posted for this study.