Clinical trial · Interventional

Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma

NCT00193258CI-TRIAL-00009206completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Conditions

Conditions (1)

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

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Bevacizumab	Drug	Bevacizumab	ALIAS
Erlotinib	Drug	Erlotinib	ALIAS
Imatinib	Drug	Imatinib	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Intervention
description
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
interventionNames
1. Drug: Bevacizumab
2. Drug: Erlotinib
3. Drug: Imatinib

Primary outcomes (3)

measure
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
timeFrame
18 months
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
* Previous nephrectomy is required
* Maximum of 1 previous systemic regimen for metastatic disease.
* Able to perform activities of daily living with minimal assistance
* Measurable disease
* Adequate bone marrow, liver and kidney
* Written informed consent.

Exclusion Criteria:

* Age \< 18 years
* Treatment with more than 1 previous systemic regimen
* History of heart attack within 6 months
* Clinically significant cardiovascular disease
* Moderate to severe vascular disease.
* Active brain metastases.
* History or evidence by physical examination of brain tumor
* Seizures not controlled with standard medical therapy
* history of stroke or other serious disorders of the nervous system
* Clinical history of coughing or vomiting blood within the past 3 months.
* PEG tubes or G tubes
* Chronic therapy with NSAIDS or other platelet inhibitors
* Proteinuria
* Nonhealing wound, ulcer, or long bone fracture
* Clinical evidence or history of a bleeding disorder
* Requiring full dose anticoagulation with coumadin
* Receiving chronic steroid therapy
* Significant medical conditions.
* Tumors other than clear cell
* History of stroke within 6 months.
* History of abdominal fistula,perforation,or abscess within 6 months.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

References

Publications (1)

RESULTHainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030. PMID 18272024