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

Completed · Phase 1/Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00043823

Run by

M.D. Anderson Cancer Center

People needed

41

Starts

2002-08-01

Expected to finish

2006-05-15

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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