Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)

NCT00651482 | Terminated Phase 2 Results DMC

• 5 other identifiers: IRB-11789RENAL001698593AVF4304s41839
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer

Conditions

Kidney Neoplasms; Kidney (Renal Cell) Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-free survival (PFS) per RECIST criteria

  24 months

Secondary Outcomes (8)

• Objective Response (OR)

  24 months

• Objective Response (OR) Duration

  24 months

• Time-to-Treatment Failure (TTF)

  24 months

• Overall Survival (OS)

  44 months

• Number of Subjects With Drug-related SAEs

  24 months

Study Arms (1)

Bevacizumab + RAD001 (everolimus)

EXPERIMENTAL

Study treatment, consisting of bevacizumab + everolimus, was administered as 28-day cycles Bevacizumab 10 mg/kg administered by IV infusion every 14 days (dose suspension permitted, dose reduction not permitted) Everolimus 10 mg daily was administered orally (dose reduction to 5 mg daily and then 5 mg every other day, was permitted as needed for toxicity or tolerability)

Drug: Everolimus; Drug: Bevacizumab

Interventions

Everolimus DRUG

Also known as: Zortress, Certican, RAD001

Bevacizumab + RAD001 (everolimus)

Bevacizumab DRUG

Also known as: Avastin

Bevacizumab + RAD001 (everolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Histologically confirmed metastatic RCC that is predominantly clear cell Measurable disease, as defined by RECIST
• Age ≥ 18 years
• ECOG performance status of 0 or 1
• No more than 1 prior targeted therapy (eg, sorafenib, sunitinib) (prior cytokine therapy allowed)
• No more than 2 prior systemic therapies
• Ability and capacity to comply with the study and follow-up procedures

You may not qualify if:

• Inability to comply with study and/or follow-up procedures
• Life expectancy of \< 12 weeks
• Inadequate organ function, as evidenced by any of the following at screening:
• Absolute neutrophil count (ANC) \< 1500/uL
• Platelet count ≤ 100 x 10\^9/L
• Total bilirubin ≥ 1.5 x upper limit of normal (ULN)
• AST and/or ALT \> 2.5 x ULN for patients without evidence of liver metastases, or 5 x ULN for patients with documented liver metastases
• Serum creatinine \> 2.0 mg/dL
• Hemoglobin \< 9 g/dL (may be transfused or receive epoetin alfa to maintain or exceed this level)
• Active infection or fever \> 38.5°C within 3 days of starting treatment
• Women who are pregnant or breast feeding,
• Able to conceive and unwilling to practice an effective method of birth control.
• History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
• Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Principal Investigator.
• Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a patient's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results.

Sponsors & Collaborators

• Sandy Srinivas: lead
• Genentech, Inc.: collaborator
• Novartis: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Harshman LC, Barbeau S, McMillian A, Srinivas S. A phase II study of bevacizumab and everolimus as treatment for refractory metastatic renal cell carcinoma. Clin Genitourin Cancer. 2013 Jun;11(2):100-6. doi: 10.1016/j.clgc.2012.12.002. Epub 2013 Jan 24.

  PMID: 23352238 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Everolimus; Bevacizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Associate Professor of Medicine (Oncology)
• Organization: Stanford University Medical Center

sandysri@stanford.edu

650-725-2078

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 2, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 11, 2017
• Results First Posted: July 29, 2014

Record last verified: 2017-03

Locations

US (1)