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

NCT00043823 | Completed Phase 1

• 2 other identifiers: ID01-604VICC THO 0206
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objectives:

1. 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. 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.
3. 3.(Phase I and II) To evaluate the pharmacokinetic interaction between the combination.
4. 4.(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

Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; Lung Cancer; Avastin; Bevacizumab; rhuMAb VEGF; Anti-VEGF monoclonal antibody; Tarceva; OSI-774; Erlotinib Hydrocholoride

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin

  After each 21 day cycle

Secondary Outcomes (1)

• Response in Patients With NSCLC Receiving Combination Avastin and Tarceva

  6 weeks (2 cycles)

Study Arms (1)

Avastin + Tarceva

EXPERIMENTAL

Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.

Drug: Avastin; Drug: Tarceva

Interventions

Avastin DRUG

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

Also known as: rhuMAb VEGF, Bevacizumab, Anti-VEGF monoclonal antibody

Avastin + Tarceva

Tarceva DRUG

100 mg By Mouth Daily for 3 Weeks

Also known as: OSI-774, Erlotinib Hydrocholoride

Avastin + Tarceva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator
• Vanderbilt-Ingram Cancer Center: collaborator

Study Sites (2)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roy S. Herbst, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2002
• First Posted: August 15, 2002
• Study Start: August 1, 2002
• Primary Completion: May 15, 2006
• Study Completion: May 15, 2006
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

US (2)