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

November 5, 2018 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
Time Frame: After each 21 day cycle
After each 21 day cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Response in Patients With NSCLC Receiving Combination Avastin and Tarceva
Time Frame: 6 weeks (2 cycles)
6 weeks (2 cycles)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Genentech, Inc.
Vanderbilt-Ingram Cancer Center

Investigators

  • Principal Investigator: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2002

Primary Completion (Actual)

May 15, 2006

Study Completion (Actual)

May 15, 2006

Study Registration Dates

First Submitted

August 14, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID01-604
  • VICC THO 0206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on Avastin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe