Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

NCT00601926 | Terminated Phase 2 Results DMC

• 2 other identifiers: OSU-06111NCI-2011-03160
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

papillary renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma.

  Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Up to 2 years

• Response Rate to Bevacizumab in This Population.

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.

  Up to 2 years

Secondary Outcomes (1)

• Safety of Bevacizumab in This Population of Patients

  Up to 2 years

Study Arms (1)

Bevacizumab

EXPERIMENTAL

15 mg/kg over 90 minutes

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

15 mg/kg over 90 minutes every 3 weeks

Also known as: Avastin

Bevacizumab

Eligibility Criteria

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

You may qualify if:

• ECOG (Eastern Cooperative Oncology Group) performance status 0-1
• Life expectancy \> 6 months
• ANC (absolute neutrophil count) ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST (aspartate aminotransferase) and ALT (Alanine transaminase) \< 3 times normal
• Creatinine clearance \> 50 mg/mL
• Calcium \< 12 mg/dL (when corrected for level of serum albumin)
• No known HIV infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if:

• Inadequately controlled hypertension (defined as systolic blood pressure \[BP\] \> 150 mm Hg and/or diastolic BP \> 100 mm Hg on antihypertensive medications)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association class II-IV congestive heart failure
• Myocardial infarction or unstable angina within the past 6 months
• Stroke or transient ischemic attack within the past 6 months
• Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Significant traumatic injury within the past 28 days
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious, non-healing wound, ulcer, or bone fracture
• Proteinuria at screening as demonstrated by either of the following:
• Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening
• Urine dipstick for proteinuria ≥ 2+ OR 24-hour urine protein \> 1g
• Known hypersensitivity to any component of bevacizumab

Sponsors & Collaborators

• Paul Monk: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

This trial closed early due to poor patient accrual. Attempts to open this trial at other sites were not successful.

Results Point of Contact

• Title: Paul Monk, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Paul.Monk@osumc.edu

614-293-2886

Study Officials

• Paul Monk, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: January 28, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2013
• Last Updated: June 15, 2015
• Results First Posted: February 18, 2015

Record last verified: 2015-05

Locations

US (1)