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Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043823
First Posted: August 15, 2002
Last Update Posted: April 19, 2012
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.
Collaborators:
Genentech, Inc.
Vanderbilt-Ingram Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

Primary Objectives:

  1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC).
  2. (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study.

Secondary Objectives:

  1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
  2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.

Condition Intervention Phase
Lung Cancer Drug: Avastin Drug: Tarceva Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin [ Time Frame: After each 21 day cycle ]

Secondary Outcome Measures:
  • Response in Patients With NSCLC Receiving Combination Avastin and Tarceva [ Time Frame: 6 weeks (2 cycles) ]

Enrollment: 41
Study Start Date: August 2002
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin + Tarceva
Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
Drug: Avastin
7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle
Other Names:
  • rhuMAb VEGF
  • Bevacizumab
  • Anti-VEGF monoclonal antibody
Drug: Tarceva
100 mg By Mouth Daily for 3 Weeks
Other Names:
  • OSI-774
  • Erlotinib Hydrocholoride

Detailed Description:

Patients will be treated with oral Tarceva daily for 21 days each cycle. Patients will receive Avastin by IV on day 1 of each 21-day cycle. If a patient has no grade 3 or 4 toxicities after the 1st cycle, then the patient may continue the same doses of Tarceva and Avastin for another cycle. If the patient has response or stable disease after 6 weeks (2 cycles), the patient may continue on the same doses of Tarceva and Avastin. A patient may receive treatment on this study for up to one year, unless his or her disease progresses or side effects become too severe.

The starting dose is 100 mg daily of Tarceva and 7.5 mg/kg every 21 days of Avastin.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC.
  • Patient has a Karnofsky performance status >=70%.
  • Patient has adequate bone marrow function: WBC >= 3,000 cells/mm3, ANC >= 1,500 cells/mm3, platelet count >= 100,000 cells/mm3, Hgb >= 9.0 g/dL.
  • Patient has adequate liver function: total bilirubin level <= 2.0 mg/dL, albumin >= 2.5 g/dL.
  • Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN.
  • Patient has adequate renal function: a serum creatinine < 2 mg/dl
  • Patient has signed a written informed consent.
  • Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease.

Exclusion Criteria:

  • Patient has not received prior chemotherapeutic regimens for advanced disease.
  • Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF).
  • Patient has received radiation therapy within the past 3 weeks.
  • Patient has signs or symptoms of acute infection requiring systemic therapy.
  • Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
  • Patient requires total parenteral nutrition with lipids.
  • Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (> 150/100 mmHg).
  • Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
  • Serious infection or other intercurrent illness requiring immediate therapy.
  • Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently treated CNS malignancy, as well as those experiencing recent cerebrovascular accident (CVA), or other CNS bleeding.
  • Pediatric patients in whom open growth plates would be expected.
  • Urine protein qualitative value of > 30 in urinalysis or > +1 in proteinuria testing by dipstick.
  • Patient has a clinical history of coagulopathy or thrombosis.
  • Patient is currently receiving or intending to receive anti-coagulants.
  • Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal.
  • Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery.
  • Patient has a clinical history of hemoptysis or hematemesis.
  • Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G) tube.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00043823


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genentech, Inc.
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00043823     History of Changes
Other Study ID Numbers: ID01-604
VICC THO 0206
First Submitted: August 14, 2002
First Posted: August 15, 2002
Last Update Posted: April 19, 2012
Last Verified: April 2012

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
NSCLC
Lung Cancer
Avastin
Bevacizumab
rhuMAb VEGF
Anti-VEGF monoclonal antibody
Tarceva
OSI-774
Erlotinib Hydrocholoride

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Erlotinib Hydrochloride
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action