Kidney CancerPhase 2NCT00193154
OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing OSI-774 and Bevacizumab in people with Kidney Cancer, run by SCRI Development Innovations, LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- OSI-774 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Oncology LLC
Baton Rouge, Louisiana, 70809
Grand Rapids Oncology Program
Grand Rapids, Michigan, 49503
About this study
Official title: A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
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).
Read the detailed description
Upon determination of eligibility, all patients will receive:
Tarceva + Avastin
- Conditions
- Kidney Cancer
- Being tested
- OSI-774, Bevacizumab
- Keywords
- Kidney Cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSI-774Drug
Also called Tarceva
150mg PO, days 1-28, cycle repeated every 28 days
BevacizumabDrug
Also called Avastin
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: OSI-774; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the combination of Tarceva and Avastin
Measured: 18 months
Secondary outcomes (4)
Objective response rate
Measured: 18 months
Progression-free survival
Measured: 18 months
Overall Survival
Measured: 18 months
Overall tolerability and toxicity of this combination regimen
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJan 2004
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193154
- Sponsor's protocol ID
- SCRI GU 17
- Other IDs
- AVF2488s
- Status last verified
- Mar 2014
- First submitted
- 12 Sep 2005
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16204015
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00193154
- Acronym / sponsor ID
- SCRI GU 17
- Conditions
- Kidney Cancer
- Keywords
- Kidney Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- AstraZeneca, Genentech, Inc.
- Study start
- Feb 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Upon determination of eligibility, all patients will receive:
Tarceva + Avastin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSI-774 & bevacizumab | Experimental | Drug: OSI-774, Drug: BevacizumabOSI-774 (Tarceva) 150mb PO, days 1-28; bevacizumab (Avastin) 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- Age < 18 years
- Treatment with more than one previous regimen for metastatic disease
- Clinically significant cardiovascular disease
- Active brain metastases
- History of CNS disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSI-774Also: Tarceva150mg PO, days 1-28, cycle repeated every 28 days | Drug | OSI-774 & bevacizumab |
| BevacizumabAlso: Avastin10mg/kg, IV infusion, Days 1 and 15, 28 day cycles | Drug | OSI-774 & bevacizumab |
Primary outcome
Efficacy of the combination of Tarceva and Avastin
Time frame: 18 months
4 secondary outcomes
Objective response rate
Time frame: 18 months
Progression-free survival
Time frame: 18 months
Overall Survival
Time frame: 18 months
Overall tolerability and toxicity of this combination regimen
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Results publication: PubMed 16204015Hainsworth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OSI-774 and Bevacizumab in people with Kidney Cancer, run by SCRI Development Innovations, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the combination of Tarceva and Avastin (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.