NCT00193154

Brief Summary

In this phase II trial, we plan to evaluate the combination of Tarceva and Avastin in the treatment of patients with metastatic renal cell carcinoma. This trial will be one of the first phase II trials to evaluate a combination of targeted agents in the treatment of a common solid tumor with a strong biologic rationale based on Cancer Biology (VHL/HIF/VEGF/EGFr).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

September 12, 2005

Last Update Submit

March 31, 2014

Conditions

Kidney Cancer

Keywords

Kidney Cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the combination of Tarceva and Avastin

    18 months

Secondary Outcomes (4)

  • Objective response rate

    18 months

  • Progression-free survival

    18 months

  • Overall Survival

    18 months

  • Overall tolerability and toxicity of this combination regimen

    18 months

Study Arms (1)

OSI-774 & bevacizumab

EXPERIMENTAL

OSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.

Drug: OSI-774Drug: Bevacizumab

Interventions

OSI-774DRUG

150mg PO, days 1-28, cycle repeated every 28 days

Also known as: Tarceva
OSI-774 & bevacizumab
BevacizumabDRUG

10mg/kg, IV infusion, Days 1 and 15, 28 day cycles

Also known as: Avastin
OSI-774 & bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Metastatic or unresectable clear cell kidney cancer confirmed by biopsy
  • Previous nephrectomy
  • Maximum of 1 previous regimen for metastatic disease
  • Ability to perform activities of daily living with minimal assistance
  • Measurable disease
  • Adequate bone marrow, liver and kidney function
  • Give written informed consent prior to study entry

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Age \< 18 years
  • Treatment with more than one previous regimen for metastatic disease
  • Clinically significant cardiovascular disease
  • Active brain metastases
  • History of CNS disease
  • Clinical history of coughing or vomiting blood.
  • History of thromboembolic disease.
  • PEG or G-tube are ineligible.
  • Current use of full dose anticoagulants or thrombolytic agents
  • Chronic daily treatment with aspirin or NSAIDS
  • Any clinical evidence or history of a bleeding or clotting disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical Oncology LLC

Baton Rouge, Louisiana, 70809, United States

Location

Grand Rapids Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Related Publications (1)

  • Hainsworth JD, Sosman JA, Spigel DR, Edwards DL, Baughman C, Greco A. Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol. 2005 Nov 1;23(31):7889-96. doi: 10.1200/JCO.2005.01.8234. Epub 2005 Oct 3.

    PMID: 16204015RESULT

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Erlotinib HydrochlorideBevacizumab

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John D. Hainsworth, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2003

Primary Completion

January 1, 2004

Study Completion

March 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

US(2)