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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

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate

Secondary outcome measures

Duration of Response

Overall Survival (OS)

Progression-free Survival

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

bradycardia

pneumonia

pyelonephritis

colon cancer

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1 - Bevacizumab and ErlotinibExperimental Treatment2 Interventions

All patients will be receiving fixed starting dose of bevacizumab (10 mg/kg intravenous (IV) every 2 weeks) and erlotinib (150 mg/day by mouth (PO)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erlotinib

2011

Completed Phase 4

~2290

Bevacizumab

2013

Completed Phase 4

~5280

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,584 Total Patients Enrolled

Ramaprasad Srinivasan, M.D.Principal InvestigatorNational Cancer Institute (NCI)

5 Previous Clinical Trials

142 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01130519 — Phase 2

Renal Cell Cancer Research Study Groups: 1 - Bevacizumab and Erlotinib

Renal Cell Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01130519 — Phase 2

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01130519 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of participants for this experiment?

"This clinical research is not presently open for recruitment, as it was last updated on the 1st of November 2022. However, there are many other studies recruiting participants; 541 trials to investigate neoplastic syndromes and hereditary diseases, in addition to 397 Bevacizumab-related medical experiments."

Answered by AI

Are there any openings available to people who would like to participate in this clinical trial?

"This particular medical trial has ceased to accept participants. It was first posted on the 6th of May, 2010 and it's most recent update came on November 1st 2022. For those looking for other trials, there are 541 studies searching for patients with neoplastic syndromes or hereditary issues, as well as 397 clinical trials involving Bevacizumab actively recruiting."

Answered by AI

For what indications is Bevacizumab typically prescribed?

"Bevacizumab is commonly utilized to treat recurrent non-squamous non-small cell lung cancer and can also be used for the management of malignant neoplasms, platinum-sensitive epithelial ovarian cancer, and treatment naive conditions."

Answered by AI

Has the FDA sanctioned Bevacizumab for medical treatment?

"Accruing data suggests that Bevacizumab is safe enough to receive a score of 2 on the safety scale. This evaluation was based on Phase 2 trial results, which indicated some evidence for safety but none for efficacy."

Answered by AI

Recent research and studies

Journal of Medical GeneticsJournal

Novel Mutations in FH and Expansion of the Spectrum of Phenotypes Expressed in Families with Hereditary Leiomyomatosis and Renal Cell Cancer

Wei, M-H. 2005. “Novel Mutations in FH and Expansion of the Spectrum of Phenotypes Expressed in Families with Hereditary Leiomyomatosis and Renal Cell Cancer”. Journal of Medical Genetics. BMJ. doi:10.1136/jmg.2005.033506.

Journal of Medical GeneticsJournal

Increased Risk of Cancer in Patients with Fumarate Hydratase Germline Mutation

Lehtonen, H J. 2006. “Increased Risk of Cancer in Patients with Fumarate Hydratase Germline Mutation”. Journal of Medical Genetics. BMJ. doi:10.1136/jmg.2005.036400.

American Journal of Surgical PathologyJournal

The Morphologic Spectrum of Kidney Tumors in Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) Syndrome

Merino, Maria J., Carlos Torres-Cabala, Peter Pinto, and William Marston Linehan. 2007. “The Morphologic Spectrum of Kidney Tumors in Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) Syndrome”. American Journal of Surgical Pathology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pas.0b013e31804375b8.

clinicaltrials.govStudy