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A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00081614
Recruitment Status : Completed
First Posted : April 20, 2004
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Metastases Drug: Avastin (bevacizumab) Drug: Tarceva (erlotinib HCl) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Tarceva (Erlotinib Hydrochloride) in Combination With Avastin (Bevacizumab) Versus Avastin Alone for Treatment of Metastatic Renal Cell Carcinoma
Study Start Date : March 2004
Actual Study Completion Date : July 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Histologically confirmed RCC of clear cell histology
  • Confirmed metastatic RCC
  • Age >=18 years
  • ECOG performance status of 0 or 1
  • Life expectancy >=3 months
  • Prior nephrectomy
  • Measurable disease, as defined by RECIST
  • Use of an acceptable means of contraception (potentially fertile men and women)

Exclusion Criteria:

  • RCC with predominantly sarcomatoid features
  • Prior systemic or adjuvant therapy for RCC
  • Prior radiotherapy for RCC within 28 days prior to Day 0, with the exception of single fraction radiotherapy given for the indication of pain control
  • Treatment with Avastin, Tarceva, or other agents, either investigational or marketed, that act by either EGFR inhibition or anti-angiogenesis mechanisms
  • 24-hour urine collection with >=1 g of protein
  • INR >=1.5, except for subjects receiving warfarin therapy
  • Serum creatinine >2.0 mg/dL
  • Serum calcium >10 mg/dL (corrected)
  • Absolute neutrophil count (ANC) <1500/uL
  • Platelet count <75,000/uL
  • Total bilirubin >2.0 mg/dL
  • AST or ALT >5× the upper limit of normal (ULN) for subjects with documented liver metastases; >2.5 × ULN for subjects without evidence of liver metastases
  • LDH >1.5× ULN
  • Hemoglobin <9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to maintain or exceed this level)
  • History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >160/110 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible), or Grade II or greater peripheral vascular disease
  • History of acute stroke within 6 months prior to randomization
  • Patients on dialysis
  • Other invasive malignancies, including bladder cancer and low-grade endometrial cancer, within 5 years of randomization (other than squamous or basal cell carcinoma of the skin)
  • Pregnancy or breast feeding
  • Inability to comply with study and/or follow-up procedures
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications
  • Serious, non-healing wound, ulcer, or bone fracture
  • Evidence of bleeding diathesis or coagulopathy
  • History or clinical evidence of central nervous system or brain metastases
  • History of bowel or gastric perforation
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study

    • Fine needle aspirations or core biopsies within 7 days prior to Day 0

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00081614

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Sponsors and Collaborators
Genentech, Inc.
Publications of Results:
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Responsible Party: Genentech, Inc. Identifier: NCT00081614    
Obsolete Identifiers: NCT00091221
Other Study ID Numbers: AVF2938g
First Posted: April 20, 2004    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Genentech, Inc.:
Metastatic renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Erlotinib Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action