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Renal Cell CarcinomaPhase 2NCT00081614

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

A Phase 2 study testing Avastin (bevacizumab) and Tarceva (erlotinib HCl) in people with Renal Cell Carcinoma and Metastases, run by Genentech, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma, Metastases
What is being tested?
Avastin (bevacizumab) and Tarceva (erlotinib HCl)
How many people
100 participants
Where
20 sitesUnited States
Study dates
Mar 2004to Jul 2005
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

  • 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
Show all 9Show fewer
  • Prior nephrectomy
  • Measurable disease, as defined by RECIST
  • Use of an acceptable means of contraception (potentially fertile men and women)

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • UCHSC - Urologic Oncology

    Aurora, Colorado, 80010

  • Lynn Regional Cancer Center - West

    Boca Raton, Florida, 33428

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Bay Area Cancer Research Group

    Concord, California, 94520

  • Wayne State University / Harper University Hospital

    Detroit, Michigan, 48201

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Northwestern Carolina Oncology & Hematology

    Hickory, North Carolina, 28601

  • UCLA School of Medicine

    Los Angeles, California, 90095

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Ochsner Cancer Institute

    New Orleans, Louisiana, 70121

  • NYU School of Medicine

    New York, New York, 10016

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19004

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Raleigh Hematology Oncology

    Raleigh, North Carolina, 27609

  • St. Joseph Oncology

    Saint Joseph, Missouri, 64507

  • Kaiser Permanente Medical Group

    San Diego, California, 92120

  • Bennett Cancer Center

    Stamford, Connecticut, 06902

  • Stanford University Medical Center

    Stanford, California, 94305

  • Our Lady of Mercy Medical Center

    The Bronx, New York, 10466

Other trials in United States

About this study

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

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.

Being tested
Avastin (bevacizumab), Tarceva (erlotinib HCl)
Keywords
Metastatic renal cell carcinoma
Medical subject headings
Carcinoma, Renal Cell, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avastin (bevacizumab)Drug

  • Tarceva (erlotinib HCl)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2004 (estimated)
  2. Study startMar 2004
  3. Study completionJul 2005

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081614
Sponsor's protocol ID
AVF2938g
Status last verified
May 2014
First submitted
15 Apr 2004
Last updated
16 May 2014
Results posted
No

Publications

  • 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 metastatic renal cell cancer. J Clin Oncol. 2007 Oct 10;25(29):4536-41. doi: 10.1200/JCO.2007.11.5154. Epub 2007 Sep 17.

    PubMed 17876014

  • Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.

    PubMed 37146227

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin (bevacizumab) and Tarceva (erlotinib HCl) in people with Renal Cell Carcinoma and Metastases, run by Genentech, Inc. at 20 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 9 inclusion and 27 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081614, which also lists 2 linked publications.

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 16 May 2014.

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