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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00081614
Other study ID # AVF2938g
Secondary ID
Status Completed
Phase Phase 2
First received April 15, 2004
Last updated May 14, 2014
Start date March 2004
Est. completion date July 2005

Study information

Verified date May 2014
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT00091221

Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Avastin (bevacizumab)

Tarceva (erlotinib HCl)


Locations

Country Name City State
United States UCHSC - Urologic Oncology Aurora Colorado
United States Lynn Regional Cancer Center - West Boca Raton Florida
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Our Lady of Mercy Medical Center Bronx New York
United States The Cleveland Clinic Cleveland Ohio
United States Bay Area Cancer Research Group Concord California
United States Wayne State University / Harper University Hospital Detroit Michigan
United States The Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Northwestern Carolina Oncology & Hematology Hickory North Carolina
United States UCLA School of Medicine Los Angeles California
United States North Shore University Hospital Manhasset New York
United States Ochsner Cancer Institute New Orleans Louisiana
United States NYU School of Medicine New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Raleigh Hematology Oncology Raleigh North Carolina
United States Kaiser Permanente Medical Group San Diego California
United States St. Joseph Oncology St. Joseph Missouri
United States Bennett Cancer Center Stamford Connecticut
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bukowski RM, Kabbinavar FF, Figlin RA, Flaherty K, Srinivas S, Vaishampayan U, Drabkin HA, Dutcher J, Ryba S, Xia Q, Scappaticci FA, McDermott D. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastati — View Citation

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