A Phase II, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy (Docetaxel or Pemetrexed) or Tarceva (Erlotinib) Compared With Chemotherapy (Docetaxel or Pemetrexed) Alone for Treatment of Recurrent or Refractory Non-Small Cell Lung Cancer

Genentech, Inc.48 sites in 1 country122 target enrollmentJuly 2004

ConditionsNon-Small-Cell Lung Carcinoma Neoplasm Recurrence, Local

DrugsAvastin (bevacizumab)Tarceva (erlotinib HCl)

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-Small-Cell Lung Carcinoma
Sponsor: Genentech, Inc.
Enrollment: 122
Locations: 48
Primary Endpoint: To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This Phase II, multicenter, randomized trial is designed to make preliminary evaluations of the efficacy of combining bevacizumab with chemotherapy (docetaxel or pemetrexed) or Tarceva relative to chemotherapy (docetaxel or pemetrexed) alone in patients with previously treated advanced NSCLC.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

November 2006

Last Updated

18 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent
•Histologically or cytologically proven Stage IIIb with pleural effusion, or Stage IV, recurrent non-squamous NSCLC that is recurrent and unresectable
•Progression after one line of platinum-based chemotherapy (patients who have received prior docetaxel treatment are eligible to participate if there are no contraindications for pemetrexed treatment)
•Progression after previous adjuvant chemotherapy, if therapy was completed \>= 6 months prior to randomization and the patient has received one line of therapy for recurrent disease
•(Optional) Availability of archival diagnostic tissue (paraffin tissue block or 2-10 unstained slides representative of the patient's primary cancer)
•ECOG performance status of 0, 1, or 2
•Life expectancy \>= 3 months
•Measurable disease in accordance with RECIST
•Age \>= 18 years
•Use of an acceptable means of contraception (potentially fertile men and women) or documentation of infertility

Exclusion Criteria

•More than 30 days of prior treatment with an investigational or marketed agent that acts by EGFR inhibition (those with 30 or fewer days on an EGFR inhibitor without disease progression are eligible for enrollment)
•Treatment with an investigational or marketed agent that acts by anti-angiogenic mechanisms
•Previous treatment with more than one platinum-based chemotherapy
•Chemotherapy or radiotherapy within 28 days prior to randomization
•History of hemoptysis (\> 1 teaspoon) or presence of a cavitary lesion
•Clinical history of Grade \> 2 hematemesis within 6 months or Grade 1 hematemesis within 28 days prior to randomization
•History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure \> 150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or Grade II or greater peripheral vascular disease
•History or clinical evidence of CNS or brain metastases or CNS bleeding
•History or clinical evidence of hemorrhagic or thrombotic stroke within the 6 months prior to randomization
•Centrally located lesions and lesions that abut major blood vessels

Outcomes

Primary Outcomes

To evaluate the safety and preliminary efficacy of combining bevacizumab with chemotherapy or Tarceva relative to chemotherapy alone on patients with previously treated advanced non-small cell lung cancer.