Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
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.
Checked against the public recordLast updated Nov 7, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- M.D. Anderson Cancer Center
- Interventions being studied
- Drug: Avastin; Drug: Tarceva
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Vanderbilt-Ingram Cancer CenterNashville, Tennessee
- University of Texas M.D. Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 7, 2018. Always confirm current availability with the study team.