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

NCT00043823 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-11-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Avastin

7.5 mg/kg By Vein on Day 1 of Every 21 Day Cycle

DRUG

Tarceva

100 mg By Mouth Daily for 3 Weeks

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Roy S. Herbst, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-01
Primary Completion
2006-05-15
Completion
2006-05-15

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00043823 on ClinicalTrials.gov