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Monoclonal Antibodies

Bevacizumab + Erlotinib for Renal Cell Cancer

Phase 2

Waitlist Available

Led By Ramaprasad Srinivasan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No more than two prior regimens targeting the vascular endothelial growth factor (VEGF) pathway; no prior bevacizumab therapy

Performance status Eastern Cooperative Oncology Group (ECOG) 0-2

Must not have

Concomitant therapy with potent inhibitors of Cytochrome P450 3A4 (CYP450 3A4) (e.g., ketoconazole, verapamil etc.) or with potent CYP450 1A2 inhibitors (fluoroquinolone antibiotics including ciprofloxacin, levofloxacin, and norfloxacin; ticlodipine, cimetidine, amiodarone, etc. see Appendix C)

Hypertension not controlled by medical therapy (resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg on at least two occasions over a 24 hour period despite optimal medical management)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the combination of the drugs bevacizumab and erlotinib to see how well it works in treating patients with metastatic papillary kidney cancer.

Who is the study for?

Adults diagnosed with advanced renal cell cancer linked to hereditary leiomyomatosis (HLRCC) or sporadic papillary RCC, who have not had more than two prior VEGF-targeted treatments and no bevacizumab therapy. Participants must have stable health without recent major surgeries, heart attacks, strokes, or uncontrolled conditions like high blood pressure.

What is being tested?

The trial is testing the effectiveness of combining bevacizumab (administered intravenously every two weeks) and erlotinib (a daily oral tablet) in treating metastatic HLRCC kidney cancer and sporadic papillary RCC. Patients will undergo regular monitoring through blood tests and scans during each treatment cycle.

What are the potential side effects?

Bevacizumab may cause high blood pressure, bleeding issues, slow wound healing, protein in urine; while erlotinib can lead to rash, diarrhea and liver function changes. Both drugs could potentially affect organ function or cause severe reactions if there's an allergy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2 or fewer treatments targeting blood vessel growth but never had bevacizumab.

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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It has been over 4 weeks since my major surgery and my surgical wound has healed.

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I have advanced kidney cancer, either from HLRCC or not related to HLRCC.

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I do not have any bleeding disorders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking strong medications that affect liver enzymes.

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My high blood pressure is not controlled despite taking medication.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am HIV-positive and on antiretroviral therapy.

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I am not pregnant or breastfeeding.

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I am not allergic to bevacizumab, erlotinib, or their ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks during the first 32 weeks and every 12 weeks thereafter, a median of 64.3 months for reporting.