OSI-774 and Bevacizumab in the Treatment of Patients With Metastatic Renal Cell Carcinoma
This study is ongoing, but not recruiting participants.
Sponsor:
Sarah Cannon Research Institute
Collaborators:
AstraZeneca
Genentech
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193154
First received: September 12, 2005
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: OSI-774 Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Tarceva (OSI-774) and Avastin (Bevacizumab) in the Treatment of Patients With Metastatic Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Efficacy of the combination of Tarceva and Avastin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall tolerability and toxicity of this combination regimen [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 63 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Avastin & Tarceva
Tarceva 150mb PO, days 1-28; Avastin 10mg/kg, IV infusion, days 1 and 15; Regimen will be repeated every 28 days.
|
Drug: OSI-774
150mg PO, days 1-28, cycle repeated every 28 days
Other Name: Tarceva
Drug: Bevacizumab
10mg/kg, IV infusion, Days 1 and 15, 28 day cycles
Other Name: Avastin
|
Detailed Description:
Upon determination of eligibility, all patients will be receive:
Tarceva + Avastin
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193154
Locations
| United States, Louisiana | |
| Medical Oncology LLC | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Michigan | |
| Grand Rapids Oncology Program | |
| Grand Rapids, Michigan, United States, 49503 | |
Sponsors and Collaborators
Sarah Cannon Research Institute
AstraZeneca
Genentech
Investigators
| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193154 History of Changes |
| Other Study ID Numbers: | SCRI GU 17, AVF2488s |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Kidney Cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Bevacizumab |
Erlotinib Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013