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

• Status: Completed
• Trial end date: 2006-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Genentech, Inc.; Vanderbilt-Ingram Cancer Center
• Treatments: Antibodies; Antibodies, Monoclonal; Bevacizumab; Erlotinib Hydrochloride; Immunoglobulins

Criteria

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.